FDA Adverse Event
Injury
Summary report: N
PROLENE POLYPROPYLENE SUTURE
MDR report key: 2181860
·
Received July 28, 2011
Report
- Report Number
- 2210968-2011-01016
- Event Type
- Injury
- Date Received
- July 28, 2011
- Report Date
- June 17, 2011
- Manufacturer
- ETHICON
- Product Code
- GAW
- PMA / PMN Number
- N16374
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- PHYSICIAN
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.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT UNDERWENT A BLEPHAROPLASTY ON AN UNKNOWN DATE AND SUTURE WAS USED. TOWARDS THE END OF THE PROCEDURE WHEN THE PHYSICIAN WIPED THE EYE, THE SUTURE BROKE INTO PIECES. THE PHYSICIAN HAD TO GO BACK IN AND RESUTURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROLENE POLYPROPYLENE SUTURE | SUTURE, NON-ABSORBABLE | GAW | ETHICON | NA | ZLR860 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |