MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-07-30 for HYBRESIS 199589-001 manufactured by Empi.
[6640271]
Pt complained with contusion on hip. On (b)(6) 2015, pt was referred to the physical therapist. On (b)(6) 2015, pt was treated with hybresis treatment patch on left hip. On (b)(6) 2015, pt reported rash at the follow up visit. Patch was no longer used. On (b)(6) 2015, pt was treated with steroid dose pack (medrol) and pt did not have rash. On (b)(6) 2015, pt returned with rash on right lateral abdomen and left lateral hip.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5045001 |
| MDR Report Key | 4960328 |
| Date Received | 2015-07-30 |
| Date Added to Maude | 2015-08-04 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HYBRESIS |
| Generic Name | HYBRESIS |
| Product Code | EGJ |
| Date Received | 2015-07-30 |
| Catalog Number | 199589-001 |
| Lot Number | 95841 |
| Device Expiration Date | 2016-07-01 |
| Operator | LAY USER/PATIENT |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EMPI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-30 |