FDA Adverse Event
Malfunction
Summary report: N
20 FR GASTROSTOMY TUBE
MDR report key: 1193168
·
Received October 7, 2008
Report
- Report Number
- 1527460-2008-00868
- Event Type
- Malfunction
- Date Received
- October 7, 2008
- Date of Event
- September 12, 2008
- Report Date
- September 16, 2008
- Manufacturer
- ABBOTT NUTRITION
- Product Code
- KNT
- PMA / PMN Number
- K861323
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
PER CUSTOMER, THERE IS NO SAMPLE TO RETURN. THE TUBE WAS DISCARDED.
Description of Event or Problem · 1
THE COMPLAINANT REPORTED THAT THE GASTROSTOMY TUBE DEFLATED AND FELL OUT. TREATMENT NURSE INFLATED THE BALLOON AND FOUND A HOLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 20 FR GASTROSTOMY TUBE | KNT TUBES, GASTROINTESTINAL AND ACCESSORIES | KNT | ABBOTT NUTRITION | 51364 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR |