MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-16 for INTERFERENTIAL SYS STIM 220 INTERFERENTIAL 220 STIMULATOR manufactured by Mettler Electronics, Corp..
[28452142]
Patient Sequence No: 1, Text Type: N, H10
[28452143]
During rehab, the patient had ifc unit on left ankle. In the middle of the treatment the unit increased in power then turned off. Patient did not complain of pain, no redness apparent immediately following the event. Patient saw md 10 days later; noted a small red "burn" on ankle.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5155483 |
| MDR Report Key | 5155483 |
| Date Received | 2015-10-16 |
| Date of Report | 2015-09-17 |
| Date of Event | 2015-03-23 |
| Report Date | 2015-08-18 |
| Date Reported to FDA | 2015-08-18 |
| Date Reported to Mfgr | 2015-08-18 |
| Date Added to Maude | 2015-10-16 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTERFERENTIAL SYS STIM 220 |
| Generic Name | INTERFERENTIAL CURRENT THERAPY |
| Product Code | LIH |
| Date Received | 2015-10-16 |
| Model Number | INTERFERENTIAL 220 STIMULATOR |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | METTLER ELECTRONICS, CORP. |
| Manufacturer Address | 1333 SOUTH CLAUDINA ST. ANAHEIM CA 92805 US 92805 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-10-16 |