MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-08-02 for ACTION PATCH 199488-001 manufactured by Empi, Inc..
[3678605]
It was reported to empi that a patient was burned using an action patch. The patient's diagnosis was, flexor carpi ulnaris (fcu) tendonitis of the right arm. This was the 3rd treatment. The therapy performed prior to treatment was pfn, stretching and bte. The skin was washed and dried prior to the treatment. The compound used was dexamethasone, 2. 0ml, the concentration was 10%. The patch was applied by a health professional. The patch had a lite pre-wrap placed on the electrode and was worn for 5 hours. The patient reported that there was no pain during the treatment, but thought it may have been a little itcher than the previous treatments. The irritation was noticed upon removal of the electrode, it was under the battery area of the electrode. The patient described the irritation as "bloody holes" that later scabbed over. After 2 days the surrounding area became red, raised, and itchy. The burn was said to be 1st degree. The irritation lasted 3-4 weeks. The patient did not receive medical treatment for the incident, patient purchased benadryl cream and neosporin.
Patient Sequence No: 1, Text Type: D, B5
[10978020]
This is an unusual event. The suspect device was not returned for empi to evaluate. Photos of the affected area were provided which showed nine small (. 1-. 2") circular second degree burns spread over a reddened area. Then there is one small burn outside of that area. The affected area was under the positive electrode gel. The patient and clinician both confirmed that the karaya gel was present on the patch. Patient disposed of the electrode.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1721293-2013-00003 |
| MDR Report Key | 3261621 |
| Report Source | 06 |
| Date Received | 2013-08-02 |
| Date of Report | 2013-07-09 |
| Date of Event | 2013-07-02 |
| Date Mfgr Received | 2013-07-09 |
| Device Manufacturer Date | 2013-04-09 |
| Date Added to Maude | 2013-08-02 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 6058477057 |
| 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 | ACTION PATCH |
| Generic Name | ACTION PATCH |
| Product Code | EGJ |
| Date Received | 2013-08-02 |
| Model Number | 199488-001 |
| Lot Number | 92271 |
| Device Expiration Date | 2013-12-01 |
| Operator | OTHER HEALTH CARE 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 | 2013-08-02 |