FDA Adverse Event
Injury
Summary report: N
PROLENE POLYPROPYLENE SUTURE
MDR report key: 1133194
·
Received August 21, 2008
Report
- Report Number
- 2210968-2008-00717
- Event Type
- Injury
- Date Received
- August 21, 2008
- Date of Event
- July 22, 2008
- Report Date
- July 22, 2008
- Manufacturer
- ETHICON, INC.
- Product Code
- GAW
- PMA / PMN Number
- N16374
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DATE SENT TO THE FDA: 08/21/2008. THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED HAS BEEN RECEIVED, HOWEVER, THE PRODUCT EVALUATION IS NOT YET COMPLETE. ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.
Description of Event or Problem · 1
CUSTOMER REPORTED THAT THE SUTURE BROKE FIVE DAYS FOLLOWING SURGERY. THE SURGICAL SITE SUBSEQUENTLY DEHISCED. THE PATIENT WAS RETURNED TO SURGERY FOR REPAIR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROLENE POLYPROPYLENE SUTURE | SUTURE, NON-ABSORBABLE | GAW | ETHICON, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Required Intervention |