MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-09-04 for IOMED * manufactured by Iomed, Inc..
[18144487]
Iontophoresis to left forearm. Pt reported discomfort at 4. 0ma. Decreased to 2. 0ma. After treatment noted a dark blister approx 1 cm diameter. The next day area appeared as grayish looking. Two days later there was a pus pocket with red ring around. Individual sent to er for treatment of infection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1026072 |
| MDR Report Key | 415273 |
| Date Received | 2002-09-04 |
| Date of Report | 2002-09-04 |
| Date of Event | 2002-07-30 |
| Date Added to Maude | 2002-09-11 |
| 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 | IOMED |
| Generic Name | IONTOPHORESIS |
| Product Code | KTB |
| Date Received | 2002-09-04 |
| Returned To Mfg | 2002-08-02 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | F07388 |
| ID Number | 5060004: 5000022 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 404310 |
| Manufacturer | IOMED, INC. |
| Manufacturer Address | 2441 SOUTH 3850 WEST, STE A SALT LAKE CITY UT 841209941 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2002-09-04 |