FDA Adverse Event
Injury
Summary report: N
COATED VICRYL (POLYGLACTIN 910) SUTURE
MDR report key: 1003264
·
Received February 27, 2008
Report
- Report Number
- 2210968-2008-00124
- Event Type
- Injury
- Date Received
- February 27, 2008
- Date of Event
- November 26, 2007
- Report Date
- January 29, 2008
- Manufacturer
- ETHICON, INC.
- Product Code
- GAM
- PMA / PMN Number
- K022269
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A REVIEW OF THE BATCH MFG RECORDS WAS CONDUCTED. THIS REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA. NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADD'L INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.
Description of Event or Problem · 1
INT'L CUSTOMER REPORTED THAT A PT DEVELOPED A LOCAL WOUND INFLAMMATION FOUR DAYS FOLLOWING A SKIN EXCISION PROCEDURE. THE PT WAS PRESCRIBED ANTIBIOTICS. APPROX ONE MONTH LATER, OOZING OF THE WOUND WAS STILL PRESENT, BUT NO PAIN. TWO MONTHS AFTER THE ORIGINAL PROCEDURE A PIECE OF SUTURE WAS FOUND PROTRUDING FROM THE WOUND AND WAS REMOVED. THE WOUND WAS CLEANED AND DRESSED. THE WOUND IS NOW HEALED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COATED VICRYL (POLYGLACTIN 910) SUTURE | SUTURE, ABSORBABLE | GAM | ETHICON, INC. | NA | ZA5CDLN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK YR | Required Intervention |