FDA Adverse Event
Other
Summary report: N
DAVOL
MDR report key: 141780
·
Received January 5, 1998
Report
- Report Number
- MW1012744
- Event Type
- Other
- Date Received
- January 5, 1998
- Report Date
- January 4, 1998
- Manufacturer
- DAVOL, INC. SUBSIDIARY OF C. R. BARD
- Product Code
- GCY
- Report Source
- Voluntary report
- Reporter Location
- MI, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
DAVOL RELIAVAC DRAIN BALLOON INSIDE OF CONTAINER BROKE 2CM (APPROX) "V-SHAPED" TEAR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DAVOL | RELIAVAC DRAIN | GCY | DAVOL, INC. SUBSIDIARY OF C. R. BARD | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Other |