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.
[1467107]
It was reported to empi that a pt was burned during a hybresis treatment. The treatment was on the foot of the pt and was burned in a circular pattern exactly in size to the batteries. Pt did not seek medical attention.
Patient Sequence No: 1, Text Type: D, B5
[8688790]
The actual suspect patch was not returned to empi for eval. Two unopened boxes and two unopened packages were returned of the same lot number. A sample was taken from the returned product and passed all specs. The batteries used on the patch at the time of treatment were returned also and tested. The batteries tested to specs and passed. 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 | 1721293-2010-00009 |
| MDR Report Key | 1867762 |
| Report Source | 06 |
| Date Received | 2010-10-06 |
| Date of Report | 2010-07-09 |
| Date of Event | 2009-12-18 |
| Device Manufacturer Date | 2009-12-01 |
| Date Added to Maude | 2011-02-22 |
| 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 |
| Returned To Mfg | 2010-01-14 |
| Model Number | 199589-001 |
| Lot Number | 81278 |
| Device Expiration Date | 2010-09-01 |
| 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 E. CLEAR LAKE SD 57226 US 57226 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-10-06 |