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.
[1697282]
It was reported to empi that a pt was burned during a hybresis treatment. The treatment was the 9th treatment for knee pain. The compound used was 4 mg/ml of dexamethasone 1. 5 ml on the negative side and saline on the positive side of the patch. The treatment was for 1. 5 hours in the hybresis mode. The burn was under the center of the patch by the batteries. The burn was 2 cm round and pt went to the emergency room. No medication was given to the pt.
Patient Sequence No: 1, Text Type: D, B5
[8688784]
The patch associated with the burn was returned along with 5 unused patches from the same box. The hybresis controller was also returned. The controller and the unused electrodes met electrical and physical specifications. The used electrode had a nick in the flex circuit that could have contributed to the burn. The patch was used approx one yr after the exp date. 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 | 1721293-2010-00013 |
| MDR Report Key | 1867742 |
| Report Source | 06 |
| Date Received | 2010-10-06 |
| Date of Report | 2010-07-13 |
| Date of Event | 2010-04-26 |
| Device Manufacturer Date | 2008-08-01 |
| Date Added to Maude | 2011-02-25 |
| 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 | 0 |
| 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 |
| Returned To Mfg | 2010-05-14 |
| Model Number | 199589-001 |
| Lot Number | 74488 |
| Device Expiration Date | 2009-05-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2010-10-06 |