MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-05-11 for HYBRESIS 199589-001 manufactured by Empi, Inc..
[2636149]
It was reported to empi that a patient received a burn under the battery area of the hybresis patch. The patient was diagnosed with achilles tendonitis. The compound used was dexamethasone napo4 4mg/ml, which was placed on the negative side of the patch. Saline was placed on the positive side of the patch. The therapy performed prior to this treatment was astym to the lower extremity. The treatment mode used was hybresis, lasting 2 hours. A wrap or covering was placed over the patch, but it was not compressed. The patient rated the pain at 2/10 and described it as stinging, but nothing that made him want to stop the treatment early. The burn was noted when the patch was removed. The burn was the size of a pencil eraser. The clinic reported this to be a first degree burn and that no medical intervention was needed. The patch was discarded after use.
Patient Sequence No: 1, Text Type: D, B5
[9860249]
The device will not be returned for evaluation. A failure analysis of the complaint device could not be completed. 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. Patch was discarded by user facility.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1721293-2012-00002 |
| MDR Report Key | 2571171 |
| Report Source | 05,06 |
| Date Received | 2012-05-11 |
| Date of Report | 2012-04-16 |
| Date of Event | 2012-04-11 |
| Date Mfgr Received | 2012-04-16 |
| Date Added to Maude | 2012-09-21 |
| 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 | PHYSICAL THERAPIST |
| 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 | 2012-05-11 |
| 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 | 1. Other | 2012-05-11 |