FDA Adverse Event
Other
Summary report: N
UNK
MDR report key: 47960
·
Received October 30, 1996
Report
- Report Number
- 47960
- Event Type
- Other
- Date Received
- October 30, 1996
- Date of Event
- October 17, 1996
- Report Date
- October 28, 1996
- Manufacturer
- UNK
- Product Code
- FAJ
- Report Source
- User Facility report
- Reporter Location
- PA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
DURING RETROGRADE CYSTOSCOPY FOR STENT PLACEMENT, THE LIGHT CORD FOR THE CYSTOSCOPE BURNED THE PT. THE CORD HAD BECOME UNSHIELDED SECONDARY TO USER ERROR. 1 CM BURN WITH BLISTER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNK | LIGHT CORD FOR CYSTOSCOPE | FAJ | UNK | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR | Other |