FDA Adverse Event
Injury
Summary report: N
BALLOON
MDR report key: 32673
·
Received May 2, 1996
Report
- Report Number
- MW4001167
- Event Type
- Injury
- Date Received
- May 2, 1996
- Date of Event
- August 11, 1995
- Report Date
- April 16, 1996
- Manufacturer
- BOSTON SCIENTIFIC CORP.
- Product Code
- LIT
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
BOSTON SCIENTIFIC CORP. 480 PLEASANT ST, WATERTOWN, MA 02172. NO OTHER INFO HAS BEEN PROVIDED AND OUR INVESTIGATION INTO THIS MATTER HAS PROVEN UNSUCCESSFUL. NO FURTHER DETAILS ARE AVAILABLE. THIS MFR CONSIDERS THIS COMPLAINT/MDR CLOSED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BALLOON | PERIPHERAL ANGIOPLASTY CATHETER | LIT | BOSTON SCIENTIFIC CORP. | 10X4 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO |