MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-10-17 for HYBRESIS 199589-001 manufactured by Empi, Inc..
[21976332]
The suspect device was returned, and is in the evaluation process. When the evaluation is complete, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[22097543]
It was reported that a patient used the hybresis patch on his lower back and was burned. The burn was on the very edge of the patch along the adhesive on the negative side of the patch. The compound that was used on the negative side of the patch was diclofenac sodium. The amount used on the patch was 1. 2ml and the concentration was 1%. On the opposite side of the patch was saline. The patch was worn for 2 hours in hybresis mode. The burn was approximately 1/2 inch in diameter and looked like a cigarette burn. The patient experienced stinging during the end of the treatment. The patient did not receive any medical treatment, and self diagnosed the burn as a 3rd degree.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1721293-2011-00010 |
| MDR Report Key | 2298794 |
| Report Source | 07 |
| Date Received | 2011-10-17 |
| Date of Report | 2011-09-19 |
| Date of Event | 2011-09-19 |
| Date Mfgr Received | 2011-09-19 |
| Device Manufacturer Date | 2011-06-21 |
| Date Added to Maude | 2011-10-18 |
| 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 | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS DEBBIE MIRANDA |
| Manufacturer Street | 205 HWY 22 EAST |
| Manufacturer City | CLEAR LAKE SD 57226 |
| Manufacturer Country | US |
| Manufacturer Postal | 57226 |
| Manufacturer Phone | 6058476357 |
| Manufacturer G1 | EMPI, INC. |
| Manufacturer Street | 205 HWY 22 EAST |
| Manufacturer City | CLEAR LAKE SD 57226 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 57226 |
| 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 | 2011-10-17 |
| Returned To Mfg | 2011-09-26 |
| Model Number | 199589-001 |
| Lot Number | 85223 |
| Device Expiration Date | 2013-01-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EMPI, INC. |
| Manufacturer Address | 205 HWY 22 EAST CLEAR LAKE SD 57226 US 57226 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-10-17 |