FDA Adverse Event
Other
Summary report: N
APLICARE
MDR report key: 550753
·
Received January 23, 2004
Report
- Report Number
- 550753
- Event Type
- Other
- Date Received
- January 23, 2004
- Date of Event
- December 8, 2003
- Report Date
- January 23, 2004
- Manufacturer
- APLICARE, INC
- Product Code
- GEC
- Report Source
- User Facility report
- Reporter Location
- FL, US
- Reporter Occupation
- INVALID DATA
Narratives
Description of Event or Problem · 1
POST OP OPERATIVE ASSESSMENT OF TWO PATIENTS NOTED A REDDENED AREA ON SKIN AREAS WHICH WERE FELT TO BE BETADINE BURNS OCCURRING ON THE SAME MORNING. THESE BURNS WERE NOTED TO BE FIRST DEGREE. THIS HAS NOT HAPPENED FOR SOME TIME. THE PREVIOUS (AND FIRST) CLUSTER OF THIS TYPE OF SUPERFICIAL BETADINE PREP INJURIES, MANY MONTHS AGO, HAD BEEN DIRECTLY REPORTED TO THE MANUFACTURER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | APLICARE | POVIDONE IODINE SCRUB - PREP/CLEANSING SOLUTION | GEC | APLICARE, INC | WET SKIN PREP TRAY 'REORDER: DYND70660' (MEDLINE) | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | NO OTHER THERAPIES |