FDA Adverse Event
Injury
Summary report: N
PROLENE POLYPROPYLENE SUTURE
MDR report key: 1931604
·
Received December 10, 2010
Report
- Report Number
- 2210968-2010-01676
- Event Type
- Injury
- Date Received
- December 10, 2010
- Report Date
- November 10, 2010
- Manufacturer
- ETHICON, INC.
- Product Code
- GAW
- PMA / PMN Number
- N16374
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4): CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. 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 A VALVE REPAIR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. FOUR WEEKS POST OPERATIVELY, THE SUTURE BROKE AND THE PATIENT HAD TO RETURN FOR SURGICAL REPAIR. ADDITIONAL INFORMATION WAS REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROLENE POLYPROPYLENE SUTURE | SUTURE, NON-ABSORBABLE | GAW | ETHICON, INC. | NA | BPM911 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |