MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-10-01 for HYBRESIS 199589-001 manufactured by Empi, Inc..
[2888998]
It was reported to empi that a patient was burned under the battery area of the hybresis patch. The patient was being treated for tensynovitis of ecrb/ecrl, radial styloid, trapezium scaphoid. The compound used was dexamethasone, 1. 5 cc and concentration was. 4%. The dexamethasone was placed on the negative side of the patch and saline solution was placed on the positive side of the patch. The mode used was hybresis and the patch was worn for two hours. The patient did not feel pain or discomfort during the therapy. When the patch was removed the patient saw a dark circle under the battery area of the patch. This was a second degree burn. The patient received basic first aid for the burn/wound.
Patient Sequence No: 1, Text Type: D, B5
[10141366]
The investigation showed that there was a break in the dielectric layer covering the conductive trace in the flex circuit. This defect could have caused this injury. This incident is similar to a complaint received by empi that suggests that this device may have malfunctioned in such a way that it could cause a serious injury.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1721293-2012-00005 |
| MDR Report Key | 2766063 |
| Report Source | 05 |
| Date Received | 2012-10-01 |
| Date of Report | 2012-07-17 |
| Date of Event | 2012-07-17 |
| Date Mfgr Received | 2012-07-17 |
| Device Manufacturer Date | 2011-01-01 |
| Date Added to Maude | 2012-10-01 |
| 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 | OCCUPATIONAL THERAPIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| 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 | 2012-10-01 |
| Returned To Mfg | 2012-09-20 |
| Model Number | 199589-001 |
| Lot Number | 84158 |
| Device Expiration Date | 2011-11-01 |
| Operator | OCCUPATIONAL THERAPIST |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2012-10-01 |