FDA Adverse Event
Injury
Summary report: N
PDS II (POLYDIOXANONE) SUTURE
MDR report key: 919919
·
Received September 28, 2007
Report
- Report Number
- 2210968-2007-00905
- Event Type
- Injury
- Date Received
- September 28, 2007
- Date of Event
- June 1, 2007
- Report Date
- August 30, 2007
- Manufacturer
- ETHICON, INC.
- Product Code
- GAM
- PMA / PMN Number
- N18331
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DATE SENT TO THE FDA: 9/28/2007. NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADD'L INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. THE ACTUAL DEVICE ASSOCIATED WITH THIS EVENT IS NOT KNOWN. INTERNATIONAL AFFILIATE REPORTS THE FOLLOWING POSSIBLE PRODUCTS: LOT: ZE5CSTN, MFG: 5/27/2007, EXP: UNK LOT: XEZ060, MFG: 5/1/2006, EZP: 1/31/2011.
Description of Event or Problem · 1
INTERNATIONAL CUSTOMER REPORTED THAT A PT PRESENTED WITH AN INFECTION THREE TO FIVE DAYS FOLLOWING COLO-RECTAL SURGERY. THE PT WAS PRESCRIBED ANTIBIOTICS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PDS II (POLYDIOXANONE) SUTURE | SUTURE, ABSORBABLE | GAM | ETHICON, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Required Intervention | SUTURES- SILK |