FDA Adverse Event
Injury
Summary report: N
PDS II (POLYDIOXANONE) SUTURE
MDR report key: 1141023
·
Received August 27, 2008
Report
- Report Number
- 2210968-2008-00741
- Event Type
- Injury
- Date Received
- August 27, 2008
- Report Date
- July 28, 2008
- Manufacturer
- ETHICON, INC.
- Product Code
- GAM
- PMA / PMN Number
- N18331
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED. THIS REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES, AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.
Description of Event or Problem · 1
CUSTOMER REPORTED THAT THE SUTURE DISSOLVED TOO QUICKLY AFTER SURGERY; THE PATIENT EXPERIENCED A SURGICAL WOUND DEHISCENCE. THE PATIENT WAS RETURNED TO SURGERY FOR REPAIR. SURGEON REPORTS THAT THE SURGICAL KNOTS WERE INTACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PDS II (POLYDIOXANONE) SUTURE | SUTURE, ABSORBABLE | GAM | ETHICON, INC. | NA | AC6383 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |