MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-07 for IONTOPHORESIS manufactured by Unk.
[110616373]
While physical therapy for medial epicondylitis in my left elbow, an iontophoresis treatment was administered by the physical therapist. During this treatment, i experienced pain in my left wrist, and discomfort which progressed to numbness in my left hand. The treatment lasted about 15 minutes, however this pain lasted for about 4 hours, and the numbness and discomfort continued for about 2 hours after the treatment ended. Iontophoresis: (b)(6) 2018.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5077707 |
| MDR Report Key | 7582286 |
| Date Received | 2018-06-07 |
| Date of Report | 2018-06-05 |
| Date of Event | 2018-06-05 |
| Date Added to Maude | 2018-06-08 |
| 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 | PATIENT |
| 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 | IONTOPHORESIS |
| Generic Name | IONTOPHORESIS DEVICE |
| Product Code | EGJ |
| Date Received | 2018-06-07 |
| Device Availability | N |
| 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 | 2018-06-07 |