FDA Adverse Event
Injury
Summary report: N
PERCUFLEX
MDR report key: 282033
·
Received June 16, 2000
Report
- Report Number
- 282033
- Event Type
- Injury
- Date Received
- June 16, 2000
- Date of Event
- May 23, 2000
- Report Date
- May 30, 2000
- Manufacturer
- MEDI-TECH, INC.
- Product Code
- FAD
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- PA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
RIGHT URETERAL STENT INSERTED IN 2000 FOR TREATMENT OF RENAL CALCULI. DISLODGED. RETURN TO SURGERY FOR REMOVAL/REPLACEMENT IN 2000. REPLACEMENT WITH 6X24 CM. STENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PERCUFLEX | URETERAL STENT | FAD | MEDI-TECH, INC. | 145-409 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 21 YR | Required Intervention |