FDA Adverse Event
Malfunction
Summary report: N
RELIAVAC 100 MEDIUM SUCTION 100 CC
MDR report key: 2042567
·
Received March 29, 2011
Report
- Report Number
- 2042567
- Event Type
- Malfunction
- Date Received
- March 29, 2011
- Report Date
- March 29, 2011
- Manufacturer
- BARD
- Product Code
- GCY
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- FL, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
THE MD STATES THIS IS THE SECOND TIME DURING A FOLLOW-UP VISIT IN THE OFFICE THAT THE WOUND EVACUATOR HAS LOST THE GREEN PIECE. THE SURGEON BROUGHT THE DEVICE TO THE HOSPITAL TO SHOW WHICH PIECE. THIS DEVICE HAS BEEN MAILED TO THE COMPANY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RELIAVAC 100 MEDIUM SUCTION 100 CC | CLOSED WOUND SUCTION EVACUATOR | GCY | BARD | 0070850 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |