FDA Adverse Event
Malfunction
Summary report: N
SAFESEPT
MDR report key: 3346681
·
Received September 3, 2013
Report
- Report Number
- 3346681
- Event Type
- Malfunction
- Date Received
- September 3, 2013
- Report Date
- September 3, 2013
- Manufacturer
- PRESSURE-PRODUCTS MEDICAL SUPPLIES, INC.
- Product Code
- DYB
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MT, US
Narratives
Description of Event or Problem · 1
SAFESEPT WIRE NOT STRAIGHTENING OUT WHEN PULLED INTO SHEATH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 436795 | SAFESEPT | GUIDEWIRE | DYB | PRESSURE-PRODUCTS MEDICAL SUPPLIES, INC. | SS-135 | D102349 | |
| 436796 | * | --- |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR |