FDA Adverse Event
Injury
Summary report: N
BARD, DAVOL INC.
MDR report key: 2074967
·
Received April 27, 2011
Report
- Report Number
- MW5020420
- Event Type
- Injury
- Date Received
- April 27, 2011
- Date of Event
- March 23, 2011
- Report Date
- April 27, 2011
- Manufacturer
- BARD, DAVOL INC.
- Product Code
- FTL
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- TX, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
I WAS IMPLANTED A XENMATRIX SURGICAL GRAFT AT THE CLEVELAND CLINIC BY DR (B)(6) TO REPAIR A HERNIA VENTRAL. I WAS IN HOSP FROM (B)(6) 2011. DUE TO HIGH FEVER OF 103 DEGREES FAHRENHEIT, I WAS READMITTED TO HOSP ON (B)(6) 2011.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BARD, DAVOL INC. | XENMATRIX SURGICAL GRAFT | FTL | BARD, DAVOL INC. | HUVABL14 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Hospitalization |