MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-01-23 for APLICARE WET SKIN PREP TRAY 'REORDER: DYND70660' (MEDLINE) MEDLINE WET SKIN PREP TRAY - ' manufactured by Aplicare, Inc.
[352269]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 550753 |
| MDR Report Key | 550753 |
| Date Received | 2004-01-23 |
| Date of Report | 2004-01-23 |
| Date of Event | 2003-12-08 |
| Report Date | 2004-01-23 |
| Date Reported to FDA | 2004-01-23 |
| Date Added to Maude | 2004-10-26 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | APLICARE |
| Generic Name | POVIDONE IODINE SCRUB - PREP/CLEANSING SOLUTION |
| Product Code | GEC |
| Date Received | 2004-01-23 |
| Model Number | WET SKIN PREP TRAY 'REORDER: DYND70660' (MEDLINE) |
| Catalog Number | MEDLINE WET SKIN PREP TRAY - ' |
| Lot Number | UNK |
| ID Number | * |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 540269 |
| Manufacturer | APLICARE, INC |
| Manufacturer Address | 50 EAST INDUSTRIAL ROAD BRANFORD CT 06405 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-01-23 |