MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2010-10-06 for HYBRESIS 199589-001 manufactured by Empi.
[17369838]
It was reported to empi that a female pt was burned while wearing the hybresis patch. The treatment was for ankle tendonitis of the peroneal tendon. It was the pt's eighth treatment with the hybresis patch. Dexamethasone was used on the negative pad and the hybresis modality was used. The pt noticed increased sensation after the controller was removed and did not remove the patch. After 2 hours the pt removed the patch and noticed a black hole under the battery compartment. She did not report the burn to the clinic at the time. The pt was referred to her primary physician for treatment. An antibiotic was prescribed.
Patient Sequence No: 1, Text Type: D, B5
[17599721]
The suspect patch was not returned to empi for eval. However, other products from the customer's site were evaluated. Twenty-eight sample patches from 15 lots were evaluated. Two samples had battery voltages slightly lower than specified. Of the two patches that did not meet electrical specs, one had the hybresis patch misaligned when assembled, and the other had the lower voltage on the battery but was assembled correctly. The other returned patches tested all met physical and electrical specs. Neither of the two failures would be expected to contribute to the injury. 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 would be likely to cause or contribute to a serious injury if the malfunction were to recur.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1721293-2010-00006 |
| MDR Report Key | 1867753 |
| Report Source | 06,07 |
| Date Received | 2010-10-06 |
| Date of Report | 2010-09-30 |
| Date of Event | 2010-06-22 |
| Date Mfgr Received | 2010-06-22 |
| Date Added to Maude | 2011-02-22 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | DEBBIE MIRANDA |
| Manufacturer Street | 205 HWY. 22 E. |
| Manufacturer City | CLEAR LAKE SD 57226 |
| Manufacturer Country | US |
| Manufacturer Postal | 57226 |
| Manufacturer Phone | 6058746357 |
| 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 | 2010-10-06 |
| Returned To Mfg | 2010-07-15 |
| Model Number | 199589-001 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EMPI |
| Manufacturer Address | 205 HWY. 22 E. CLEAR LAKE SD 57226 US 57226 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-10-06 |