FDA Adverse Event
Malfunction
Summary report: N
ECLIPSE HOME PUMP
MDR report key: 20157
·
Received December 7, 1994
Report
- Report Number
- MW1004342
- Event Type
- Malfunction
- Date Received
- December 7, 1994
- Report Date
- December 6, 1994
- Manufacturer
- BLOCK MEDICAL, INC.
- Product Code
- MEB
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- TX, US
- Reporter Occupation
- PHARMACIST
Narratives
Description of Event or Problem · 1
IN A SEALED PACKAGE, A HAIR WAS NOTED BETWEEN THE INNER BALLOON AND THE OUTER PLASTIC COVERING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ECLIPSE HOME PUMP | ECLIPSE HOME PUMP | MEB | BLOCK MEDICAL, INC. | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |