FDA Adverse Event
Injury
Summary report: N
MONOCRYL (POLIGLECAPRONE 25) SUTURE
MDR report key: 1233643
·
Received November 14, 2008
Report
- Report Number
- 2210968-2008-01131
- Event Type
- Injury
- Date Received
- November 14, 2008
- Date of Event
- January 1, 2008
- Report Date
- October 17, 2008
- Manufacturer
- ETHICON, INC.
- Product Code
- GAN
- PMA / PMN Number
- K964072
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DATE SENT TO THE FDA: 11/14/2008. HYPERTROPHIC SCARRING. CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. THE ACTUAL DEVICE ASSOCIATED WITH THIS EVENT IS NOT KNOWN. MONOCRYL (POLIGLECAPRONE 25) SUTURE. MONOCRYL (POLIGLECAPRONE 25) SUTURE.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT PRESENTED WITH HYPERTROPHIC SCARRING AT AN UNSPECIFIED TIME FOLLOWING BILATERAL BREAST SURGERY. UNSPECIFIED MEDICAL INTERVENTION WAS PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED; NO ADDITIONAL INFORMATION WAS RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MONOCRYL (POLIGLECAPRONE 25) SUTURE | SUTURE, ABSORBABLE | GAN | ETHICON, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention | PRINEO WOUND CLOSURE SYSTEM |