Scalpel Weekly News

Week of: June 22, 2015

IN THE NEWS


Tool Approved to Monitor Glucose Fluctuation in Young Diabetics

The FDA's Center for Devices and Radiological Health (CDRH) has approved the premarket approval application (PMA) supplement for the Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System. This device is an externally worn glucose monitoring device indicated for detecting trends and tracking patterns in persons ages 2 to 17 years with diabetes. The system is intended for single patient use and requires a prescription. Click title to continue reading...


 
MEDICAL ALERTS


Walgreens Recalls Donuts Nationwide Due to Mold Risk

Walgreen Co. of Deerfield, IL, recalled Nice! Powdered Sugar Mini Donuts, because it received consumer complaints alleging that mold was observed on some products. The Nice! Powdered Sugar Mini Donuts were distributed to Walgreens stores nationwide. Click title to continue reading...



Nationwide Recall of Chemotherapy and Other Injectables Expanded

Mylan N.V. announced that its U.S.-based Mylan Institutional business is expanding its voluntary nationwide recall to the hospital/user level of select lots of a number of injectable products due to the presence of visible foreign particulate matter observed during testing of retention samples. Click title to continue reading...



Reported Adverse Effects and Death from Synthetic Cannabinoid Use Increases

On April 6, 2015, the CDC received notice of an increase in telephone calls to U.S. poison centers related to synthetic cannabinoid use. Monthly calls to all poison centers are tracked by the National Poison Data System, which reported that adverse health effects or concerns about possible adverse health effects related to synthetic cannabinoid use increased 330% from 349 in January 2015 to 1,501 in April 2015. The 2015 figures included a spike of 1,501 calls in April, and 15 reported deaths, a three-fold increase over the five deaths that were reported in 2014. The majority of calls were made by males and the median age was 26. Click title to continue reading...


  CASE ALERTS


Catheter Piece not ‘Fixation Device’; Foreign Object Exception to Limitations Applied

A three-year-old boy underwent surgery to correct a congenital heart malformation. At the beginning of the procedure, a polyvinyl catheter was placed in the boy’s left atrium for recording atrial pressure. Before the boy was released from the operating room to the surgical intensive care unit, polyvinyl catheters were placed within the boy’s left atrium and right atrium for recording atrial pressure; myocardial pacing wires were placed upon the right atrium and right ventricle for pacing as indicated; two pericardial drainage tubes were left, one anteriorly and one posteriorly; all bleeding was stopped; and the incision was closed. Click title to continue reading...




Good Faith Expert Report; Over Anti-Coagulation; Organ Failure

A sixty-nine-year-old woman underwent back surgery. Subsequently, she was admitted to a rehabilitation center. Upon admission, the woman was assessed as having a high fall risk based on her history of multiple falls, chair-bound status, poor vision, current medications, and predisposing conditions. The admission assessment noted that the woman required two-person assists with transfer and extensive assistance from the staff for her activities of daily living. Physical and occupational therapy assessments further documented the conditions that placed the woman at a high risk of falling, but noted she had good rehabilitation potential. Click title to continue reading...



Hospital Not Vicariously Liable for Independent Doctors’ Bariatric Surgery Care

A woman underwent Roux–en–Y gastric bypass surgery to treat her obesity. Following the surgery, the woman experienced persistent abdominal pain, inability to eat, excessive weight loss, and malnourishment. She was repeatedly hospitalized for continuing treatment of the complications arising out of the gastric bypass surgery. Click title to continue reading...


FEATURE


Illustrative Complaint: Negligent Bariatric Surgery and Post-Surgical Care

This Feature enhances the Medical Law Perspectives, June 2015 Report: Gastric Bypass, Sleeve Gastrectomy, Lap Banding and More: Risks of Patient Injury and Provider Malpractice in Weight-Loss Surgery. Click title to continue reading...