FDA Adverse Event
Malfunction
Summary report: N
PRUITT IRRIGATION OCCLUSION CATHETER
MDR report key: 43198
·
Received September 6, 1996
Report
- Report Number
- 1049753-1996-00001
- Event Type
- Malfunction
- Date Received
- September 6, 1996
- Report Date
- September 6, 1996
- Manufacturer
- IDEAS FOR MEDICINE, INC.
- Product Code
- DQT
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
CATHETER BALLOON BURST DURING SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRUITT IRRIGATION OCCLUSION CATHETER | EMBOLECTOMY IRRIGATION OCCLUSION CATHETER | DQT | IDEAS FOR MEDICINE, INC. | 9F-10 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |