FDA Adverse Event
Injury
Summary report: N
MONOCRYL POLIGLECAPRONE 25 SUTURE
MDR report key: 5470671
·
Received March 1, 2016
Report
- Report Number
- 2210968-2016-05550
- Event Type
- Injury
- Date Received
- March 1, 2016
- Report Date
- February 8, 2016
- Manufacturer
- ETHICON INC.
- Product Code
- GAN
- PMA / PMN Number
- K960653
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
IT WAS REPORTED THAT THIS DEVICE IS NOT REPORTABLE. THEREFORE, THIS MEDWATCH REPORT IS NOT REPORTABLE
Additional Manufacturer Narrative · 1
(B)(4). CONCLUSION CODE: TO DATE, THE DEVICE HAS NOT BEEN RETURNED. IF THE PRODUCT IS RETURNED FOR EVALUATION, ANY FURTHER INFO DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT UNDERWENT A SCAR REVISION PROCEDURE IN EARLY DECEMBER AND SUTURE WAS USED. ONE WEEK FOLLOWING THE PROCEDURE, THE PATIENT DEVELOPED HIVES AND HAD SEEN A DERMATOLOGIST. THE PATIENT ALSO REPORTED THAT THE DERMATOLOGIST OPINED THAT THE RECOVERY VARIED FROM PATIENT TO PATIENT AS TO HOW LONG THE SUTURE WOULD TAKE TO ABSORB INTO THE BODY. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 125994 | MONOCRYL POLIGLECAPRONE 25 SUTURE | SUTURE, ABSORBABLE, SYNTHETIC | GAN | ETHICON INC. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |