FDA Adverse Event
Injury
Summary report: N
MALLINCKRODT MEDICAL, INC.
MDR report key: 69989
·
Received January 9, 1997
Report
- Report Number
- 69989
- Event Type
- Injury
- Date Received
- January 9, 1997
- Date of Event
- November 8, 1996
- Report Date
- November 18, 1996
- Manufacturer
- MALLINCKRODT MEDICAL, INC.
- Product Code
- KOD
- Adverse Event
- Yes
- Report Source
- User Facility report
- Reporter Location
- TN, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
FEEDING TUBE (8 FR) USED IN ATTEMPT TO CATHERIZE INFANT. UNABLE TO REMOVE. X-RAY TAKEN. TUBE FOUND TO BE IN KNOT IN URETHRA. PT TAKEN TO SURGERY AND TUBE REMOVED SUCCESSFULLY. INVESTIGATION REVEALS NO DEVICE MALFUNCTION OR DEFECT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MALLINCKRODT MEDICAL, INC. | INFANT FEEDING TUBE | KOD | MALLINCKRODT MEDICAL, INC. | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 26 DAY | Required Intervention | ||
| 2 |