FDA Adverse Event
Injury
Summary report: N
COATED VICRYL (POLYGLACTIN 910) SUTURE
MDR report key: 2821822
·
Received November 6, 2012
Report
- Report Number
- 2210968-2012-07061
- Event Type
- Injury
- Date Received
- November 6, 2012
- Date of Event
- October 11, 2012
- Report Date
- October 10, 2012
- Manufacturer
- ETHICON, INC.
- Product Code
- GAM
- PMA / PMN Number
- K022269
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- PHYSICIAN
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. 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 TRABECULECTOMY ON (B)(6) 2012 AND SUTURE WAS USED. ON (B)(6) 2012, THE PATIENT EXPERIENCED A WOUND DEHISCENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COATED VICRYL (POLYGLACTIN 910) SUTURE | SUTURE, ABSORBABLE | GAM | ETHICON, INC. | NA | EBM898 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |