MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-04-03 for POLYCHROME MEDICAL SC 98202340 * manufactured by Polychrome Medical.
[15439677]
Stimulation unit produced blisters on pt's forearm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1028072 |
| MDR Report Key | 452325 |
| Date Received | 2003-04-03 |
| Date of Report | 2003-04-03 |
| Date of Event | 2003-03-04 |
| Date Added to Maude | 2003-04-09 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POLYCHROME MEDICAL |
| Generic Name | CF INDICATOR |
| Product Code | KTB |
| Date Received | 2003-04-03 |
| Model Number | SC 98202340 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 441318 |
| Manufacturer | POLYCHROME MEDICAL |
| Manufacturer Address | 2700 FREEWAY BLVD SUITE 750 BROOKLYN MN 55430 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2003-04-03 |