FDA Adverse Event
Injury
Summary report: N
CAPROFYL
MDR report key: 3973393
·
Received August 1, 2014
Report
- Report Number
- 2210968-2014-10587
- Event Type
- Injury
- Date Received
- August 1, 2014
- Date of Event
- December 30, 2014
- Report Date
- July 10, 2014
- Manufacturer
- ETHICON INC.
- Product Code
- GAM
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT UNDERWENT A CESAREAN SECTION ON (B)(6) 2013 AND SUTURE WAS USED. TWENTY DAY POST-OPERATIVE THE PATIENT DEVELOPED A PUERPERAL INFECTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 451210 | CAPROFYL | SUTURE - ABSORBABLE | GAM | ETHICON INC. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR | Required Intervention |