FDA Adverse Event
Injury
Summary report: N
MONOCRYL (POLIGLECAPRONE 25) SUTURE
MDR report key: 1842866
·
Received September 17, 2010
Report
- Report Number
- 2210968-2010-01125
- Event Type
- Injury
- Date Received
- September 17, 2010
- Report Date
- August 18, 2010
- Manufacturer
- ETHICON, INC.
- Product Code
- GAN
- PMA / PMN Number
- K964072
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- 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.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PT UNDERWENT A TOTAL KNEE PROCEDURE ON AN UNK DATE AND SUTURE WAS USED AS INTERRUPTED STITCH TO CLOSE THE SUBCUTANEOUS TISSUE. POST-OPERATIVELY SUTURE SPITTING OCCURRED. THE PT RETURNED FOR AN INCISION AND DRAINAGE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MONOCRYL (POLIGLECAPRONE 25) SUTURE | SUTURE, ABSORBABLE | GAN | ETHICON, INC. | NA | CEM316 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |