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.
[1838929]
It was reported that a research project to determine if calcific deposits in the patellar tendon of the knee can be reduced using a regimen of 5% acetic acid delivered by hybresis iontophoresis. After 142 minutes of delivery via the hybresis protocol, no negative effects were noted under the placebo pad, but a second degree chemical burn the size of the drug reservoir was noted. The pt was seen by a surgeon and noted the burn to be third degree, surgery was performed to remove the dead skin.
Patient Sequence No: 1, Text Type: D, B5
[8765653]
The device will not be returned for evaluation. A failure analysis of the complaint device could not be completed. The lot number is unk. A review of the manufacturing documentation could not be performed. The university and other state agencies were looking into the injury and the bottle that supposedly contained 5% acetic acid. The investigation showed that the bottle labeled as 5% acetic acid actually contained a much higher concentration. Thus, they hybresis iontophoresis patch was not the cause of the burn.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1721293-2010-00017 |
| MDR Report Key | 1864777 |
| Report Source | 06 |
| Date Received | 2010-10-06 |
| Date of Report | 2010-10-05 |
| Date of Event | 2010-09-07 |
| Date Mfgr Received | 2010-08-19 |
| Date Added to Maude | 2010-10-14 |
| 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 |
| 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 | 2010-10-06 |
| Model Number | 199589-001 |
| Lot Number | UNK |
| Operator | OTHER |
| 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. Required No Informationntervention | 2010-10-06 |