MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-09-23 for SEPRAFILM * manufactured by Genzyme.
[330151]
Pt underwent subtotal colectomy with ileosigmoid re-anastamosis. Post operatively patient became febrile. Pt returned to o. R. For exploratory laparotomy. Inflammation found. Film removed. Pt's symptoms improved.
Patient Sequence No: 1, Text Type: D, B5
[379156]
Add'l info rec'd from mfr 11/20/03: in this report, the pt's event were described as "inflammatory/foreign body reaction". The pt received seprafilm and within 4-6 hours developed abdominal pain, tachycardia, neutropenia, fever, and hypotension. The pt rapidly recovered after re-operation with removal of seprafilm. As noted in the report, the operating surgeon considered he pt event to be probably related to seprafilm. The us package insert for seprafilm indicates that foreign body reactions can occur with sepriafilm, as with any implantable material. Continued worldwide safety monitoring as well as preliminary results from a recently completed 5 year study do not indicate an increased risk of foreign body reactions compared to what has been reported in the package insert.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 485075 |
| MDR Report Key | 485075 |
| Date Received | 2003-09-23 |
| Date of Report | 2003-09-23 |
| Date of Event | 2003-09-15 |
| Date Facility Aware | 2003-09-16 |
| Date Reported to FDA | 2003-09-23 |
| Date Reported to Mfgr | 2003-09-23 |
| Date Added to Maude | 2003-09-29 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SEPRAFILM |
| Generic Name | ADHESION BARRIER |
| Product Code | MLQ |
| Date Received | 2003-09-23 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 567043 |
| ID Number | * |
| Device Expiration Date | 2005-10-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 479169 |
| Manufacturer | GENZYME |
| Manufacturer Address | 5175 SOUTH ROYAL ATLANTA DR TUCKER GA 30084 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2003-09-23 |