MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2015-02-25 for HYBRESIS 199589-001 manufactured by Empi, Inc.
[5515487]
It was reported that a patient received a 3rd degree burn during an iontophoresis treatment on the back of the left heel/ankle area. Patients' diagnosis is left achilles tendonitis. The treatment date was (b)(6) 2014 and this was the seventh treatment with the iontophoresis patch. The compound used was dexamethasone, concentration was 0. 4%. The amount used was approximately 1. 3ml. The compound was placed on the negative side of the patch and saline solution was added to the positive side of the patch. The skin was prepared with alcohol. The mode was hybresis 80ma/min and the patch was worn for 2 hours. The patch was applied to the patient by a health professional. The treatment area was compressed, the patient put her sock and shoe on after the treatment patch was applied. The clinic stated that over a period of visits the pad placement was adjusted to assure there was as minimal pressure from shoe, but also covering and treating the painful area. Patient felt more irritation than normal after she left the clinic and then for longer than normal after removing the patch. The irritation was under the negative side of the patch. The burn looks like a cigarette burn, black in color and was diagnosed by the clinic to be a third degree burn. The patient did not receive medical treatment for the incident, and progress toward recover was not impeded because of this incident.
Patient Sequence No: 1, Text Type: D, B5
[12846782]
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 | 1721293-2015-00002 |
| MDR Report Key | 4544917 |
| Report Source | 05,06,07 |
| Date Received | 2015-02-25 |
| Date of Report | 2015-01-30 |
| Date of Event | 2015-01-20 |
| Date Mfgr Received | 2015-01-30 |
| Device Manufacturer Date | 2014-12-01 |
| Date Added to Maude | 2015-02-25 |
| 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 | 2015-02-25 |
| Model Number | 199589-001 |
| Device Expiration Date | 2016-06-16 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2015-02-25 |