FDA Adverse Event
Malfunction
Summary report: N
BUTTON REPL., G-DEVICE
MDR report key: 280262
·
Received May 25, 2000
Report
- Report Number
- 1223688-2000-00021
- Event Type
- Malfunction
- Date Received
- May 25, 2000
- Date of Event
- January 31, 2000
- Report Date
- April 27, 2000
- Manufacturer
- C.R. BARD, INC., BIPD DIV.
- Product Code
- KNT
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHARMACIST
Narratives
Description of Event or Problem · 1
BUTTON PLACED IN 1999. WHEN REMOVING IT IN 2000 THE USER NOTED THAT THE INTERNAL DOME WAS MISSING. NO OTHER INFORMATION IS AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BUTTON REPL., G-DEVICE | FEEDING DEVICE | KNT | C.R. BARD, INC., BIPD DIV. | 61000285 | 43JIA003 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |