FDA Adverse Event
Other
Summary report: N
APLICARE
MDR report key: 551144
·
Received January 23, 2004
Report
- Report Number
- 551144
- 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
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. THE BURNS WERE FIRST DEGREE. THIS HAS NOT HAPPENED FOR SOME TIME. THE PREVIOUS (AND FIRST) CLUSTER OF THIS TYPE OF SUPERFICIAL BETADINE PREP INJURY, 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 PRE-OP SCRUB SOLUTION | GEC | APLICARE, INC. | MEDLINE 'WET SKIN PREP TRAY' -R EORDER:DYND70660 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR |