FDA Adverse Event
Malfunction
Summary report: N
GASTROSTOMY TUBE
MDR report key: 33261
·
Received May 30, 1996
Report
- Report Number
- MW1009185
- Event Type
- Malfunction
- Date Received
- May 30, 1996
- Date of Event
- May 24, 1996
- Report Date
- May 27, 1996
- Manufacturer
- MEDICAL INNOVATIONS CORP.
- Product Code
- KNT
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MI, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
BALLOON BROKEN, NEW GASTROSTOMY TUBE HAD TO BE INSERTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GASTROSTOMY TUBE | BALLOON | KNT | MEDICAL INNOVATIONS CORP. | 5020301 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 93 YR |