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.
[1466616]
It was reported to empi that a pt was burned during a hybresis treatment. The pt was being treated for post tib tendonitis. Dexamethasone at 1. 25ml was used on the negative side, and saline on the positive side. The patch was worn for 2 hours and the pt describes the burning as intermittent. The burn was 4mm in diameter and red with eschar. No medical intervention was required.
Patient Sequence No: 1, Text Type: D, B5
[8686421]
No product returned. 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 | 1721293-2010-00011 |
| MDR Report Key | 1867746 |
| Report Source | 06 |
| Date Received | 2010-10-06 |
| Date of Report | 2010-07-12 |
| Date of Event | 2010-03-01 |
| Device Manufacturer Date | 2010-01-01 |
| Date Added to Maude | 2012-01-06 |
| 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 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 | 81612 |
| Device Expiration Date | 2010-10-01 |
| 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 |