MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-04-01 for HYBRESIS 199589-001 manufactured by Empi.
[19941034]
The device will not be returned for evaluation. A failure analysis of the complaint device could not be completed. A review of the device history record showed no issues. The frequency and severity of the event is within the expected limits. We could not determine the cause of the event.
Patient Sequence No: 1, Text Type: N, H10
[20089606]
It was reported to empi on (b)(6) 2011 that a patient suffered a burn under the negative side of the hybresis electrode patch. On (b)(6) 2011, it was reported that the burn was third degree. On (b)(6) 2011, the patient was being treated for medial and lateral epicondylitis. Before the hybresis treatment, the patient received mfr followed by ultrasound to the forearm. For the hybresis treatment, the compound used was dexamethasone, the concentration was 4. 0 mg/ml, and the amount of dexamethasone used was 2. 0 ml. The treatment mode used was hybresis. The patient reported pain during the 3-minute initial treatment using the controller. The patch was worn for an additional 2 hours. It was reported that this was the patient's twelfth hybresis treatment. The patient returned that afternoon to the clinic with a 1 cm diameter burn. The area was black, charred and no blisters. The clinician reported that the burn was under the negative pad. To the clinician's knowledge the patient did not receive medical attention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1721293-2011-00001 |
| MDR Report Key | 2048420 |
| Report Source | 06 |
| Date Received | 2011-04-01 |
| Date of Report | 2011-03-31 |
| Date of Event | 2011-02-14 |
| Date Mfgr Received | 2011-02-18 |
| Device Manufacturer Date | 2010-11-01 |
| Date Added to Maude | 2011-04-13 |
| 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 EAST |
| 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 | 2011-04-01 |
| Model Number | 199589-001 |
| Lot Number | 83420 |
| Device Expiration Date | 2011-07-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 1. Other | 2011-04-01 |