FDA Adverse Event
Injury
Summary report: N
COATED VICRYL (POLYGLACTIN 910) SUTURE
MDR report key: 3031461
·
Received April 2, 2013
Report
- Report Number
- 2210968-2013-03334
- Event Type
- Injury
- Date Received
- April 2, 2013
- Date of Event
- January 21, 2013
- Report Date
- March 11, 2013
- Manufacturer
- ETHICON, INC.
- Product Code
- GAM
- PMA / PMN Number
- K022269
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PE
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
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 2210968-2013-03335. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.
Description of Event or Problem · 1
IT WAS REPORTED THAT A (B)(6) PATIENT UNDERWENT A FINGER AMPUTATION PROCEDURE BECAUSE THE PATIENT WAS BORN WITH SIX FINGERS AND SUTURE WAS USED INTRADERMALLY. THE PATIENT DEVELOPED A GRANULOMA. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 133563 | COATED VICRYL (POLYGLACTIN 910) SUTURE | SUTURE, ABSORBABLE | GAM | ETHICON, INC. | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |