FDA Adverse Event
Malfunction
Summary report: N
ADAP 2000
MDR report key: 618938
·
Received August 10, 2004
Report
- Report Number
- 1056553-2004-00001
- Event Type
- Malfunction
- Date Received
- August 10, 2004
- Date of Event
- July 21, 2004
- Report Date
- August 10, 2004
- Manufacturer
- REMINGTON MEDICAL, INC.
- Product Code
- DSA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- INVALID DATA
Narratives
Description of Event or Problem · 1
CUSTOMER STATED THAT WHEN THEY CONNECTED OUR BLACK PLUG INTO THE MEDTRONIC 5388 THE BLACK PLUG BROKE - ALSO STATED WHEN THEY TRIED TO REMOVE CO'S PLUG FROM THE MEDTRONIC DEVICE THE PLUG BROKE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ADAP 2000 | DISPOSABLE ADAPTER | DSA | REMINGTON MEDICAL, INC. | ADAP 2000 | 033505 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |