MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-01-23 for APLICARE MEDLINE 'WET SKIN PREP TRAY' -R EORDER:DYND70660 APLICARE RE-ORDER NO. 82-364 , manufactured by Aplicare, Inc..
[17250422]
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
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 551144 |
| MDR Report Key | 551144 |
| 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 | 2004-10-27 |
| 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 | 0 |
| 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 PRE-OP SCRUB SOLUTION |
| Product Code | GEC |
| Date Received | 2004-01-23 |
| Model Number | MEDLINE 'WET SKIN PREP TRAY' -R EORDER:DYND70660 |
| Catalog Number | APLICARE RE-ORDER NO. 82-364 , |
| Lot Number | * |
| ID Number | * |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 540663 |
| Manufacturer | APLICARE, INC. |
| Manufacturer Address | 50 EAST INDUSTRIAL ROAD BRANFORD CT 06405 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-01-23 |