FDA Adverse Event
Malfunction
Summary report: N
HMP 2112
MDR report key: 24865
·
Received February 14, 1995
Report
- Report Number
- 1056436-1994-09003
- Event Type
- Malfunction
- Date Received
- February 14, 1995
- Date of Event
- August 22, 1994
- Report Date
- August 24, 1994
- Manufacturer
- HDC
- Product Code
- MDX
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- NJ, US
- Reporter Occupation
- INVALID DATA
Narratives
Description of Event or Problem · 1
PT RECEIVED HMP 2112 ON 6/27/94. THE LOCKING MECHANISM CAME OFF AND DR. CUASAY HAD TO REPLACE THE LOCING MECHANISM. THE PLACED THE LOCING MECHANISM ON 8/22/94.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HMP 2112 Implant | IMPLANTABLE DRUG PORT | MDX | HDC | 2112 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR |