FDA Adverse Event
Injury
Summary report: N
MEDI. TECH BOSTON SCIENTIFIC CORP.
MDR report key: 223902
·
Received May 6, 1999
Report
- Report Number
- 223902
- Event Type
- Injury
- Date Received
- May 6, 1999
- Date of Event
- January 28, 1999
- Report Date
- March 3, 1999
- Manufacturer
- MEDI TECH BOSTON SCIENTIFIC CORP.
- Product Code
- DTK
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
VENA CAVA UMBRELLA DID NOT DEPLOY - SURGEON WAS ABLE TO REINSERT AND DEPLOY ANOTHER DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MEDI. TECH BOSTON SCIENTIFIC CORP. Implant | * | DTK | MEDI TECH BOSTON SCIENTIFIC CORP. | * | 2108164 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR | Required Intervention |