FDA Adverse Event
Injury
Summary report: N
MESH - COMPOSIX KUGEL
MDR report key: 624771
·
Received August 3, 2005
Report
- Report Number
- 1213643-2005-00132
- Event Type
- Injury
- Date Received
- August 3, 2005
- Report Date
- July 21, 2005
- Manufacturer
- DAVOL INC., SUB. C.R. BARD, INC.
- Product Code
- FTL
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
"SOME TIME IN MARCH 2005 IT OCCURRED THAT SOME DAYS AFTER IMPLANT THE PT RETURNED TO THE CLINIC IN PAIN. AFTER THOROUGH EXAMINATION A BROKEN RING WAS DETECTED. THE COMPOSIX KUGEL PATCH WAS EXPLANTED. THE BROKEN RING SHOWED TOWARD THE ABDOMINAL WALL NOT TOWARDS THE INTESTINES. THE HEAD OF THE SURGICAL DEPARTMENT WAS ANGRY AND DID NOT INSERT ANY MORE COMPOSIX KUGEL PATCHES. CO ONLY FOUND OUT BECAUSE CO MADE AN APPOINTMENT WITH THE HOSPITAL, SINCE THE LAST ORDER WAS PLACE IN MARCH."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MESH - COMPOSIX KUGEL | SURGICAL MESH | FTL | DAVOL INC., SUB. C.R. BARD, INC. | * | 43EOD238 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Required Intervention |