FDA Adverse Event
Injury
Summary report: N
COATED VICRYL (POLYGLACTIN 910) SUTURE
MDR report key: 664109
·
Received January 13, 2006
Report
- Report Number
- 2210968-2006-00067
- Event Type
- Injury
- Date Received
- January 13, 2006
- Report Date
- December 16, 2005
- Manufacturer
- ETHICON, INC.
- Product Code
- GAM
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
CODE: JV372; LOT: UM8HCPM0; MFG: 11/2005; EXP: 12/31/2010. JV372; UJ8BJQM0; 08/2005; 12/31/2010. JV372; UE8GJKM0; 05/2005; 06/30/2010. JV372; UG8HBXM0; 06/2005; 06/30/2010. JV323; UD8DXRM0; 04/2005; 06/30/2010. JV323; UE8JPPM0; UNK; 06/30/2010. CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME.
Description of Event or Problem · 1
A PATIENT PRESENTED AT AN UNSPECIFIED TIME FOLLOWING SURGERY WITH AN UNSPECIFIED INFECTION. IT IS ASSUMED THAT ANTIBIOTICS WERE PRESCRIBED TO ADDRESS THE EVENT. NO FURTHER DETAILS WERE PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COATED VICRYL (POLYGLACTIN 910) SUTURE | SUTURE, ABSORBABLE | GAM | ETHICON, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |