FDA Adverse Event
Injury
Summary report: N
VICRYL POLYGLACTIN 910 SUTURE
MDR report key: 4243427
·
Received November 11, 2014
Report
- Report Number
- 2210968-2014-15584
- Event Type
- Injury
- Date Received
- November 11, 2014
- Date of Event
- October 23, 2014
- Report Date
- October 23, 2014
- 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
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGICAL PROCEDURE FOLLOWING CHILDBIRTH ON AN UNKNOWN DATE AND SUTURE WAS USED. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED SUTURE SPITTING AND DELAYED WOUND HEALING DUE TO FISTULAS. THE PATIENT IS BEING TREATED BY AN ALLERGIST AND THE PHYSICIAN OPINES THE PATIENT MAY HAVE DEVELOPED SINUSES RATHER THAN FISTULAS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 725699 | VICRYL POLYGLACTIN 910 SUTURE | SUTURE, ABSORBABLE, SYNTHETIC | GAM | ETHICON INC. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |