FDA Adverse Event
Death
Summary report: N
MANUAL ENDOSCOPIC ROTATIONAL CLIP APPLIER
MDR report key: 91125
·
Received May 16, 1997
Report
- Report Number
- 1044475-1997-00005
- Event Type
- Death
- Date Received
- May 16, 1997
- Date of Event
- May 1, 1997
- Report Date
- May 9, 1997
- Manufacturer
- WECK CLOSURE SYSTEMS, LLC
- Product Code
- HBT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MX
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
DEATH OCCURRED FROM POSSIBLE CLIP CLOSURE FAILURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MANUAL ENDOSCOPIC ROTATIONAL CLIP APPLIER | MANUAL CLIP APPLIER | HBT | WECK CLOSURE SYSTEMS, LLC | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO | Death |