MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-11-30 for HYBRESIS 199589-001 manufactured by Empi, Inc..
[2981694]
It was reported to empi that a patient was burned during a hybresis treatment. The patient was diagnosed with right knee pain. The therapy performed before the treatment was massage and therapeutic exercise. The compound used was dexamethaxone, 1. 4ml concentration was 0. 4%. The compound was placed on the negative side of the patch and saline was placed on the positive side of the patch. The hybresis treatment was for two hours and in hybresis mode. The patient noticed irritation, burning and stinging within the first hour into the treatment, but left the patch on for two hours. The degree of burn was second degree, and under the battery area of the patch. The patient did not receive medical treatment for this incident.
Patient Sequence No: 1, Text Type: D, B5
[10258940]
The device was not returned for investigation. This report is being submitted because empi has received a similar complaint that suggests that this device may have malfunctioned in such a way that it could have contributed to this injury. Patch disgarded by user.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1721293-2012-00007 |
| MDR Report Key | 2853151 |
| Report Source | 07 |
| Date Received | 2012-11-30 |
| Date of Report | 2012-11-07 |
| Date of Event | 2012-10-04 |
| Date Mfgr Received | 2012-11-07 |
| Date Added to Maude | 2013-03-07 |
| 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 |
| 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 | 2012-11-30 |
| Model Number | 199589-001 |
| Lot Number | UNKNOWN |
| 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 | 2012-11-30 |