MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2014-05-02 for HYBRESIS 199589-001 manufactured by Empi, Inc.
[4361489]
It was reported to empi that a patient received a 3rd degree burn during a hybresis treatment. The injury was on the anterior left shoulder, the diagnosis was s/p rtc repair; biceps tendonitis. This was the 2nd treatment. The skin was cleaned with alcohol prior to the treatment. The compound used was dexamethasone at 0. 4% concentration and 1. 5ml was used on the negative side of the hybresis patch. The mode was hybresis and the treatment was for 2 hours for 80ma minute. The therapy performed prior to the treatment was, therapeutic excercise, manual therapy to include soft tissue, joint mobilization and prom (passive range of motion). The treatment area was not compressed and there was no wrap or covering on the electrode. The patient noticed the burn upon removal of the patch and the physical therapist was notified. The burn was under the negative side of the patch. There was discomfort, pain and redness around the area of the burn. The patient did not receive medical treatment for the incident. Progress toward recovery was not impeded because of this incident. The patient has not experienced this type of issue with the hybresis patch before.
Patient Sequence No: 1, Text Type: D, B5
[11782411]
The hybresis patch that was used will not be returned for evaluation. If more information becomes available then a follow-up report will be filed. Patch was discarded by patient.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1721293-2014-00004 |
| MDR Report Key | 3786448 |
| Report Source | 05,07 |
| Date Received | 2014-05-02 |
| Date of Report | 2014-04-03 |
| Date of Event | 2014-03-20 |
| Date Mfgr Received | 2014-04-02 |
| Device Manufacturer Date | 2014-01-28 |
| Date Added to Maude | 2014-05-02 |
| 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 | PHYSICAL THERAPIST |
| 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 | 6058747057 |
| 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 | 2014-05-02 |
| Model Number | 199589-001 |
| Lot Number | 93821 |
| Device Expiration Date | 2015-07-01 |
| Operator | PHYSICAL THERAPIST |
| Device Availability | N |
| 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 | 2014-05-02 |