FDA Adverse Event
Injury
Summary report: N
COATED VICRYL (POLYGLACTIN 910) SUTURE
MDR report key: 3003829
·
Received March 14, 2013
Report
- Report Number
- 2210968-2013-02440
- Event Type
- Injury
- Date Received
- March 14, 2013
- Report Date
- February 18, 2013
- Manufacturer
- ETHICON, INC.
- Product Code
- GAM
- PMA / PMN Number
- K022269
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, 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. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2013-02441. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL ABDOMINAL HYSTERECTOMY ON (B)(6) 2012 AND SUTURE WAS USED ON THE FASCIA. THE PATIENT PRESENTED WITH TENDERNESS AND SKIN BLISTERS FROM THE THIGHS TO THE UMBILICUS. ANTIBIOTICS WERE GIVEN TO THE PATIENT. WHEN THE ANTIBIOTICS ARE STOPPED THE SYMPTOMS REAPPEAR. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 106760 | COATED VICRYL (POLYGLACTIN 910) SUTURE | SUTURE, ABSORBABLE | GAM | ETHICON, INC. | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |