MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2010-10-06 for HYBRESIS 199589-001 manufactured by Empi.
[1694908]
It was reported to empi that a pt was burned during a hybresis treatment. The pt was being treated for achilles tendonitis with dexamethosone 1. 5 ml sodium phosphate. The pt experienced discomfort, and a sharp pain on the negative side of the patch under the battery pack. The pt seen the burn immediately after removing the patch, but did not call the physical therapist dept until 4:45 pm. The burn was small, black necrosis in the center. The pt threw the patch away after the treatment.
Patient Sequence No: 1, Text Type: D, B5
[8688787]
The hybresis patch was not returned to empi for eval. Three dose controllers and one charger were returned. The three dose controllers and the charging station all met electrical and physical requirements. 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 | 1721293-2010-00008 |
| MDR Report Key | 1867751 |
| Report Source | 06 |
| Date Received | 2010-10-06 |
| Date of Report | 2010-07-09 |
| Date of Event | 2009-12-07 |
| Date Mfgr Received | 2009-12-15 |
| Date Added to Maude | 2010-11-16 |
| 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 |
| Model Number | 199589-001 |
| Lot Number | UNK |
| 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 E. CLEAR LAKE SD 57226 US 57226 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-10-06 |