MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-03-27 for IONTOPHORESIS TREATMENT PATCH manufactured by Empi.
[2571419]
On (b)(6) 2012, an iontophoresis treatment patch was placed on the base of the neck onto the right shoulder with iontophoresis treatment completed over 10 minutes at 1 unit and then the patch delivering medication slowly over approximately 3 hours. The pt returned on (b)(6) 2012 reporting to staff of a slight skin burn over the posterior right shoulder where the previous treatment was done. This wasn? T noticed by the pt until later in the day after receiving the iontophoresis treatment. No specific additional care was required for the outcome.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5024817 |
| MDR Report Key | 2513017 |
| Date Received | 2012-03-27 |
| Date of Report | 2012-03-27 |
| Date of Event | 2012-03-14 |
| Date Added to Maude | 2012-04-03 |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IONTOPHORESIS TREATMENT PATCH |
| Generic Name | TREATMENT PATCH ? HYBRESIS BY EMPI |
| Product Code | EGJ |
| Date Received | 2012-03-27 |
| Lot Number | 199589-001 "87967" |
| ID Number | REFERENCE#: 199589 |
| Device Expiration Date | 2013-01-08 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EMPI |
| Manufacturer Address | EAST CKEARLAKE SD 57226 US 57226 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-03-27 |