FDA Adverse Event
Malfunction
Summary report: N
TYSHAK DILATATION CATHETER
MDR report key: 288005
·
Received July 27, 2000
Report
- Report Number
- 1318694-2000-00005
- Event Type
- Malfunction
- Date Received
- July 27, 2000
- Date of Event
- November 2, 1998
- Report Date
- July 25, 2000
- Manufacturer
- NUMED, INC.
- Product Code
- LIT
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE BALLOON BURST LONGITUDINALLY AT 1ATM DURING AN UNSPECIFIED PROCEDURE. THERE WAS NO REPORT OF AN INJURY TO THE PT. NUMED CONTACTED THE DISTRIBUTOR WHO PROVIDED THE INITIAL REPORT TO NUMED BUT THE CO COULD NOT OBTAIN ANY ADD'L INFO ABOUT THIS MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TYSHAK DILATATION CATHETER | PTA CATHETER | LIT | NUMED, INC. | 102 | T-1119 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |