FDA Adverse Event
Malfunction
Summary report: N
PEG TUBE, 20 FR
MDR report key: 17527
·
Received November 9, 1994
Report
- Report Number
- MW1003964
- Event Type
- Malfunction
- Date Received
- November 9, 1994
- Date of Event
- October 26, 1994
- Report Date
- October 28, 1994
- Manufacturer
- MEDICAL INNOVATIONS CORP.
- Product Code
- KNT
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- FL, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
PEG PLACEMENT; WIRE ON PEG PULLED LOOSE FROM ATTACHMENT SITE. DEFECTIVE TUBE REMOVED AND NEW PEG INSERTED. DEVICE AND PHOTOS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PEG TUBE, 20 FR | PEG | KNT | MEDICAL INNOVATIONS CORP. | 40317001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Other |