MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-03-17 for IONTOPHOR II 6111PM/DX manufactured by Wr Medical Electronics Co (formerly Life-tech).
[70243638]
Labeling and/or instructions for use will be modified to better ensure use of compatible components and proper technique.
Patient Sequence No: 1, Text Type: N, H10
[70243639]
Burn during iontophoresis treatment. Site reported two patients with burns and provided photos of one patient's injury. Neither required medical intervention to treat the burn other than one patient may have received antibiotics to prevent any possible complications. Site reported that a ground electrode intended for emg was used instead of the manufacturer's recommended iontophoresis return electrode as is stated in the device manual. Site also reported that they believed the burn was located at the active electrode site.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2118418-2017-00001 |
| MDR Report Key | 6414468 |
| Report Source | USER FACILITY |
| Date Received | 2017-03-17 |
| Date of Report | 2017-02-23 |
| Date of Event | 2017-02-02 |
| Date Mfgr Received | 2017-02-02 |
| Device Manufacturer Date | 2008-11-24 |
| Date Added to Maude | 2017-03-17 |
| 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 | MEDICAL ASSISTANT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KYLE MALONEY |
| Manufacturer Street | 1700 GERVAIS AVE |
| Manufacturer City | MAPLEWOOD MN 55109 |
| Manufacturer Country | US |
| Manufacturer Postal | 55109 |
| Manufacturer Phone | 6516048400 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IONTOPHOR II |
| Generic Name | IONTOPHOR II |
| Product Code | EGJ |
| Date Received | 2017-03-17 |
| Returned To Mfg | 2017-02-20 |
| Model Number | 6111PM/DX |
| Operator | MEDICAL ASSISTANT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WR MEDICAL ELECTRONICS CO (FORMERLY LIFE-TECH) |
| Manufacturer Address | 1700 GERVAIS AVE MAPLEWOOD MN 55109 US 55109 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-03-17 |