FDA Adverse Event
Injury
Summary report: N
COATED VICRYL PLUS ANTIBACTERIAL SUTURE
MDR report key: 702585
·
Received April 21, 2006
Report
- Report Number
- 2210968-2006-00314
- Event Type
- Injury
- Date Received
- April 21, 2006
- Report Date
- March 30, 2006
- Manufacturer
- ETHICON, INC.
- Product Code
- GAM
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
RESULT & CONCLUSION: IMPLANT SURGERY WAS PERFORMED ON SAMPLES RECEIVED FOR EVALUATION. THE RESULTS INDICATE THAT THE SAMPLES RETAINED 75.01% BREAKING STRENGTH RETENTION AT 21 DAYS POST-IMPLANTATION. NO DEVICE FAILURE DETECTED AND THE DEVICE WAS WITHIN SPECIFICATION FOR % BREAKING STRENGTH RETENTION.
Additional Manufacturer Narrative · 1
NO CONCLUSION CAN BE DRAWN AT THIS TIME. 510(K)# K022715.
Description of Event or Problem · 1
CUSTOMER REPORTED THAT A PT PRESENTED WITH A SURGICAL WOUND DEHISCENCE AT AN UNSPECIFIED TIME FOLLOWING TOTAL KNEE SURGERY. THE PT WAS RETURNED TO THE OR FOR SURGICAL REPAIR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COATED VICRYL PLUS ANTIBACTERIAL SUTURE | SUTURE, ABSORBABLE | GAM | ETHICON, INC. | NA | UP7083 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |