FDA Adverse Event
Other
Summary report: N
LIGHT SOURCE
MDR report key: 32207
·
Received March 19, 1996
Report
- Report Number
- 32207
- Event Type
- Other
- Date Received
- March 19, 1996
- Date of Event
- March 7, 1996
- Report Date
- March 8, 1996
- Manufacturer
- STORZ INSTRUMENT CO.
- Product Code
- FCW
- Adverse Event
- Yes
- Report Source
- User Facility report
- Reporter Location
- NJ, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
DR COMPLETED PROCEDURE AND PLACED LIGHT CORD ON PT DRAPE. LIGHT TURNED OFF BY NURSE. ON REMOVAL OF DRAPE A 1 1/2 CM (DIME SIZE) BLISTER WAS NOTED. THERE WAS A BURN NOTED IN DRAPE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIGHT SOURCE | LIGHT CORD | FCW | STORZ INSTRUMENT CO. | 9175, 495NB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Other |