MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-06-20 for ACTIVAPATCH IONTOGO 4.0 NC89189 manufactured by North Coast Medical.
[111734341]
There is no specific information regarding the injuries such as size, depth, or site beneath electrode. There are no photos of the "burns". The anatomical locations included the hips, knees, shoulders and elbow. The exact number of patients is not stated. The complaint states some patients were treated with ultrasound prior to iontophoresis. Ifu states patients should not be treated with ultrasound prior to iontophoresis. How many of the patients were treated with ultrasound is not stated. The treatment of the burns and the outcome is not stated.
Patient Sequence No: 1, Text Type: N, H10
[111734342]
Pt used patches on individual who may have had ultrasound prior to use. After use patient received skin irritation/electrical burn. May have gone to primary care physician for treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000124207-2018-00009 |
| MDR Report Key | 7621006 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-06-20 |
| Date of Report | 2018-06-19 |
| Date of Event | 2018-01-23 |
| Date Added to Maude | 2018-06-20 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Street | NO.48 LANE 392 FU TEH 1ST RD XI HI DIST |
| Manufacturer City | NEW TAIPEI CITY, TAIWAN CHINA 221 |
| Manufacturer Country | TW |
| Manufacturer Postal | 221 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACTIVAPATCH IONTOGO 4.0 |
| Generic Name | ACTIVAPATCH IONTOGO |
| Product Code | EGJ |
| Date Received | 2018-06-20 |
| Catalog Number | NC89189 |
| Lot Number | BEW161001 |
| Operator | PHYSICAL THERAPIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NORTH COAST MEDICAL |
| Manufacturer Address | 780 SUITE 100 JARVIS MORGAN HILL CA 95037 US 95037 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-06-20 |