FDA Adverse Event
Injury
Summary report: N
MESH - COMPOSIX KUGEL
MDR report key: 873120
·
Received June 26, 2007
Report
- Report Number
- 1213643-2007-00403
- Event Type
- Injury
- Date Received
- June 26, 2007
- Report Date
- June 27, 2007
- Manufacturer
- DAVOL INC., SUB. C.R. BARD, INC.
- Product Code
- FTL
- PMA / PMN Number
- K003323
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THERE HAS BEEN NO PRODUCT RETURNED FOR EVALUATION. THEREFORE, NO CONCLUSION CAN BE DRAWN.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED IN 2006, AND DEVELOPED AN INFECTION LASTING FOR TWO MONTHS. THE WOUND WAS LEFT OPEN SINCE IT WOULD NOT HEAL AFTER THE SURGERY. THE PATIENT WAS ALSO DIAGNOSED AS HAVING UTI DURING HIS LAST VISIT TO THE DOCTOR'S OFFICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MESH - COMPOSIX KUGEL | FTL | DAVOL INC., SUB. C.R. BARD, INC. | 43CPD337 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Other |