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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

Model number

NA

Catalog 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