MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-11-11 for HYBRESIS 117114-MACHINE/ISSU manufactured by Empi.
[1654736]
Pt had hybresis/iontophoresis at last pt visit (b)(6) 2010 - 10th into treatment, using hybresis 9 out of 10 times-. Pt reports that she left that patch on for the allocated 2 hours following her treatment session, when she took the patch off she reports that the electrode was black and discolored. Later her skin pigmentation darkened/reddened in the area where the patch had been. Patch was thrown away by pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5018198 |
| MDR Report Key | 1900987 |
| Date Received | 2010-11-11 |
| Date of Report | 2010-11-11 |
| Date of Event | 2010-10-05 |
| Date Added to Maude | 2010-11-30 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HYBRESIS |
| Generic Name | NONE |
| Product Code | EGJ |
| Date Received | 2010-11-11 |
| Model Number | 117114-MACHINE/ISSU |
| Lot Number | 82675-PATCH |
| Device Expiration Date | 2011-04-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EMPI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-11-11 |