FDA Adverse Event
Injury
Summary report: N
MESH - COMPOSIX
MDR report key: 1933819
·
Received December 14, 2010
Report
- Report Number
- 1213643-2010-00554
- Event Type
- Injury
- Date Received
- December 14, 2010
- Report Date
- November 19, 2010
- Manufacturer
- DAVOL INC., SUB. C.R. BARD, INC.
- Product Code
- FTL
- PMA / PMN Number
- K971745
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
WE HAVE CONTACTED THE INITIAL REPORTER TO REQUEST ADDITIONAL INFORMATION AND TO REQUEST RETURN OF THE DEVICE FOR EVALUATION. THIS MDR INCLUDES ALL PATIENT, EVENT AND DEVICE INFORMATION DAVOL HAS RECEIVED TO DATE. CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED NOR HAS A SPECIFIC PRODUCT PROBLEM BEEN REPORTED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.
Description of Event or Problem · 1
THE FOLLOWING WAS REPORTED TO DAVOL BY THE ATTORNEY FOR THE PATIENT: PATIENT SUSTAINED INJURY AND DAMAGES ASSOCIATED WITH USE OF DEFECTIVE PRODUCT, COMPOSIX MESH. SPECIFICALLY, AS A RESULT OF HAVING THE COMPOSIX MESH PATCH IMPLANTED, PATIENT SUFFERED DISABLING PAIN AND REQUIRED SURGICAL INTERVENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MESH - COMPOSIX | FTL | DAVOL INC., SUB. C.R. BARD, INC. | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Required Intervention |