MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-03-04 for MACRODUCT SWEAT COLLECTION SYSTEM SS-032 * manufactured by Wescor.
[401416]
Pt suffered a second degree burn from exposure to electrodes when pilogel disc broke into pieces during pilocarpine iontophoesis procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1034995 |
| MDR Report Key | 585483 |
| Date Received | 2005-03-04 |
| Date of Report | 2005-03-03 |
| Date of Event | 2005-02-24 |
| Date Added to Maude | 2005-03-30 |
| 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 | 3 |
| Reporter Occupation | ATTORNEY |
| 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 | MACRODUCT SWEAT COLLECTION SYSTEM |
| Generic Name | PILOGEL DISC |
| Product Code | KTB |
| Date Received | 2005-03-04 |
| Model Number | SS-032 |
| Catalog Number | * |
| Lot Number | P5028 |
| ID Number | * |
| Device Expiration Date | 2007-01-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 575331 |
| Manufacturer | WESCOR |
| Manufacturer Address | 459 SOUTH MAIN STREET LOGAN UT 84321 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 1 | 1. Required No Informationntervention | 2005-03-04 |