BARRIER EXTRA PROTECTION PLUS GOWN, EXTRA LARGE
Received May 21, 2003 · Event occurred Apr 20, 2003
Report 2523357-2003-00005 · MDR key 461768
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 IMPERVIOUS GOWN. THE CUSTOMER ALLEGED STRIKETHROUGH OF FLUID IN THE ABDOMEN. A TOTAL OF FIVE INCIDENTS WERE REPORTED FORM THIS HOSPITAL FOR THE FOLLOWING: 1) BOWEL RESECTION, 2) INCISION AND DRAPE (I&D) - TWO SURGEONS, 3) TOTAL HIP REPLACEMENT AND 4) SEVERE GUNSHOT WOUND. THIS REPORT IS FILED FOR NO. 4 ABOVE; MS. FITZPATRICK, VISITED THE HOSPITAL AND WAS UNABLE TO GATHER ADDITIONAL INFO FOR THIS REPORT. NO BLOODBORNE PATHOGEN EXPOSURE WAS REPORTED.
Remedial action
- Other