MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-11-19 for HYBRESIS manufactured by Empi.
[1813458]
Pt was in physical therapy treatment and had iontophoresis treatment patch placed on left shoulder on (b)(6) 2010. Returned for another treatment on (b)(6) 2010, and complained of a small burn on her shoulder. Stated that had to remove the patch early on (b)(6) 2010, because it was painful. Examined by physician, and noted 1/2 cm burn that was healing. Eschar in place. Treated with antibiotic ointment. This was the second treatment. No previous problems with the first treatment. Dose or amount: one patch; frequency: one time use; route: top. Dates of use: (b)(6) 2010. Diagnosis or reason for use: shoulder pain. Event abated after use stopped or dose reduced: yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5018307 |
| MDR Report Key | 1908964 |
| Date Received | 2010-11-19 |
| Date of Report | 2010-11-19 |
| Date of Event | 2010-11-12 |
| Date Added to Maude | 2010-11-29 |
| 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 | RISK MANAGER |
| 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 | IONTOPHORESIS PATCH |
| Product Code | EGJ |
| Date Received | 2010-11-19 |
| Lot Number | 199589-001 82675 |
| Device Expiration Date | 2011-04-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EMPI |
| Manufacturer Address | 205 HWY 22 EAST CLEAR LAKE SD 57226 US 57226 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-11-19 |