MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2012-03-06 for HYBRESIS 199589-001 manufactured by Empi, Inc..
[2395096]
The following information was reported to empi: a patient received a 3rd degree burn to his upper left arm, with resulting scarring. The burn was under the negative polarity of the patch. The mode used was hybresis. The patient experienced pain almost from the beginning of the treatment. A wrap or covering was placed over the electrode, but the treatment area was not compressed. The patient did receive medical treatment for the incident, and progress towards recovery was impeded. After the patch was removed, a burn mark was visible on the underside of the patch closer to the negative electrode.
Patient Sequence No: 1, Text Type: D, B5
[9673087]
The suspect device was not returned to empi for evaluation. A follow up report will be submitted if more information becomes available. A review of the hybresis user manual was performed. It states: "advise the patient to report immediately any pain during treatment. If the patient complains of pain, pause the treatment, inspect the area under the patch and make necessary adjustments (e. G. Reposition the patch to ensure full skin contact, decrease current, etc. ) before resuming the treatment or discontinue the treatment. " "do not tape or bind the patch during treatment. " a device history record (dhr) review was performed, and no issues were found. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1721293-2012-00001 |
| MDR Report Key | 2480675 |
| Report Source | 00 |
| Date Received | 2012-03-06 |
| Date of Report | 2012-02-06 |
| Date of Event | 2012-01-25 |
| Date Mfgr Received | 2012-02-06 |
| Device Manufacturer Date | 2012-02-01 |
| Date Added to Maude | 2012-03-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS DEBBIE MIRANDA |
| Manufacturer Street | 205 HWY 22 EAST |
| Manufacturer City | CLEAR LAKE SD 57226 |
| Manufacturer Country | US |
| Manufacturer Postal | 57226 |
| Manufacturer Phone | 6058477057 |
| Manufacturer G1 | EMPI, INC. |
| Manufacturer Street | 205 HWY 22 EAST |
| Manufacturer City | CLEAR LAKE SD 57226 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 57226 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HYBRESIS |
| Generic Name | HYBRESIS |
| Product Code | EGJ |
| Date Received | 2012-03-06 |
| Model Number | 199589-001 |
| Lot Number | 87481 |
| Device Expiration Date | 2013-07-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EMPI, INC. |
| Manufacturer Address | 205 HWY 22 EAST CLEAR LAKE SD 57226 US 57226 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-03-06 |