MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-09 for CHATTANOOGA DEVICE, IONTOPHORESIS manufactured by Unk.
[144962006]
Pt had appt for second trial of iontophoresis. Pt did not notice any burning sensation during the procedure. When electrode was removed later in the day, a small black area under the electrode was noted. Pt was seen the next day was diagnosed with a 0. 5 cm circular burn. This was consistent with an electrical burn. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086552 |
| MDR Report Key | 8600644 |
| Date Received | 2019-05-09 |
| Date of Report | 2019-05-06 |
| Date of Event | 2019-04-29 |
| Date Added to Maude | 2019-05-10 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CHATTANOOGA DEVICE, IONTOPHORESIS |
| Generic Name | DUAL CHANNEL IONTOPHORESIS SYSTEM |
| Product Code | EGJ |
| Date Received | 2019-05-09 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-05-09 |