FDA Adverse Event
Injury
Summary report: N
PROLENE POLYPROPYLENE SUTURE
MDR report key: 3161945
·
Received June 11, 2013
Report
- Report Number
- 2210968-2013-06972
- Event Type
- Injury
- Date Received
- June 11, 2013
- Report Date
- May 15, 2013
- Manufacturer
- ETHICON, INC.
- Product Code
- GAW
- PMA / PMN Number
- N16374
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4). CONCLUSION: 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 AN UNKNOWN PROCEDURE ON (B)(6) 2013 AND SUTURE WAS USED. THE SUTURE BROKE POST OPERATIVE, REQUIRING A REOPERATION TO CLOSE THE INCISION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 263226 | PROLENE POLYPROPYLENE SUTURE | SUTURE NON ABSORBABLE | GAW | ETHICON, INC. | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |