FDA Adverse Event
Death
Summary report: N
SEPRAFILM BIORESORBABLE MEMBRANE
MDR report key: 265252
·
Received February 24, 2000
Report
- Report Number
- 1220423-2000-00010
- Event Type
- Death
- Date Received
- February 24, 2000
- Report Date
- February 24, 2000
- Manufacturer
- GENZYME CORPORATION
- Product Code
- MCN
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
PERITONITIS, DEATH. MFR HAS BEEN MADE AWARE OF A REPORT INVOLVING A PT WHO HAD ALLEGEDLY REC'D SEPRAFILM, DEVELOPED PERITONITIS AND SUBSEQUENTLY DIED. FURTHER DETAILS AT THIS TIME ARE UNAVAILABLE AND THE RELATIONSHIP OF THE EVENTS TO SEPRAFILM IS UNKNOWN. SEVERAL UNSUCCESSFUL REQUESTS HAVE BEEN MADE TO THE ATTENDING PHYSICIAN FOR INFO REGARDING THIS CASE. A FOLLOW-UP REPORT WILL BE SUBMITTED IF THESE DETAILS ARE OBTAINED.
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 | NO INFO | Death |