FDA Adverse Event
Injury
Summary report: N
PROLENE POLYPROPYLENE SUTURE
MDR report key: 3213274
·
Received July 9, 2013
Report
- Report Number
- 2210968-2013-12625
- Event Type
- Injury
- Date Received
- July 9, 2013
- Date of Event
- June 11, 2013
- Report Date
- June 20, 2013
- Manufacturer
- ETHICON INC.
- Product Code
- GAW
- PMA / PMN Number
- N16374
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
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.
Additional Manufacturer Narrative · 1
IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2013 AND SUTURE WAS USED FOR ANTERIOR FASCIA CLOSURE. THE END OF THE NEEDLE BROKE AND REMAINED IN THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 314455 | PROLENE POLYPROPYLENE SUTURE | SUTURES - NON-ABSORBABLE | GAW | ETHICON INC. | UNK | GBP567 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |