FDA Adverse Event
Malfunction
Summary report: N
SEPRAFILM BIORESORBABLE MEMBRANE
MDR report key: 259966
·
Received January 11, 2000
Report
- Report Number
- 1220423-2000-00001
- Event Type
- Malfunction
- Date Received
- January 11, 2000
- Report Date
- January 5, 2000
- Manufacturer
- GENZYME CORPORATION
- Product Code
- MCN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
IT HAS BEEN REPORTED THAT DURING A SURGICAL PROCEDURE THE PHYSICIAN MISTAKENLY PLACED A DEMO SEPRAFILM SHEET INTO THE PT. THE DEMO HAS BEEN IDENTIFIED AND WAS CLEARLY MARKED INDICATING FOR "DEMONSTRATION USE ONLY", AND ALSO STATES "NOT FOR USE IN HUMANS". REPORTEDLY, THE SHEET HAD INADVERTENTLY BEEN BROUGHT INTO THE OPERATING ROOM AND SUBSEQUENTLY USED. SEPRAFILM'S DEMO SHEETS ARE TERMINALLY STERILIZED PRIOR TO INTRODUCTION INTO THE DEMO STOCK. THERE HAS BEEN NO KNOWN PT PROBLEMS. ADDITIONAL FOLLOW-UP INFO, IF RECEIVED, WILL BE SUBMITTED BY GENZYME CORPORATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SEPRAFILM BIORESORBABLE MEMBRANE | RESORBABLE ADHESION BARRIER | MCN | GENZYME CORPORATION | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |