MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-05-22 for IOGEL manufactured by .
[1129562]
Patient received a burn during an iontophoresis treatment on the knee. The medication used was dexamethizone. The dosage was 4. 0 for 10 minutes. The burn occurred under one electrode where the metal snap is located on the dispersive electrode. The burn was third degree and did require daily wound care. This was the patient's first iontophoresis treatment. The therapist could not provide the model number or the electrode for evaluation.
Patient Sequence No: 1, Text Type: D, B5
[8329015]
The device was not returned for evaluation. Since the device was not returned for evaluation, no root cause can be determined. The device labeling identifies adverse effects; skin irritation and burns beneath the electrodes have been reported.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1022819-2009-00147 |
| MDR Report Key | 1394226 |
| Report Source | 05 |
| Date Received | 2009-05-22 |
| Date of Report | 2009-04-29 |
| Date of Event | 2009-03-06 |
| Date Mfgr Received | 2009-04-29 |
| Date Added to Maude | 2009-06-01 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MICHAEL TREAS |
| Manufacturer Street | 4717 ADAMS RD. |
| Manufacturer City | HIXSON TN 37343 |
| Manufacturer Country | US |
| Manufacturer Postal | 37343 |
| Manufacturer Phone | 4238702281 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IOGEL |
| Product Code | KTB |
| Date Received | 2009-05-22 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-05-22 |