BARRIER EXTRA PROTECTION PLUS SURGICAL GOWN, EXTRA LARGE
Received May 21, 2003 · Event occurred Apr 20, 2003
Report 2523357-2003-00004 · MDR key 461765
Device
Generic name
Gown, Surgical
Manufacturer
Molnlycke Health Care, Inc.Model number
NACatalog number
0541
Lot number
UNK
Product problems
- Device Maintenance Issue
Patient
UNKNOWN
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
INITIAL REPORT FROM TERRITORY SALES MANAGER, CONCERNING AN ACCOUNT THAT HAD JUST CONVERTED FROM USING AN ENTIRE FLUID IMPERVIOUS GOWN TO A FLUID ZONED INPERVIOUS GOWN. THE CUSTOMER ALLEGED STRIKETHROUGH OF FLUID IN THE ABDOMEN. A TOTAL OF FIVE INCIDENTS WERE REPORTED FROM THIS HOSPITAL FOR THE FOLLOWING: 1) BOWEL RESECTION, 2) INCISION AND DRAINAGE (I&D) - TWO SURGEONS, 3) TOTAL HIP REPLACEMENT AND 4) SEVERE GUNSHOT WOUND. THIS REPORT IS FILED FOR NO. 3 ABOVE; SUBSEQUENT FOLLOW-UP BY TERRITORY SALES MANAGER WITH THE DOCTOR INVOLVED IN THE REPORTED INCIDENT FOUND THAT THE STRIKETHROUGH MAY HAVE OCCURRED IN THE THIGH/KNEE AREA, WHICH IS OUTSIDE OF THE REINFORCEMENT PANEL OF THE GOWN. NO BLOODBORRNE PATHOGEN EXPOSURE WAS REPORTED.
Remedial action
- Other