MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-16 for INTERFERENTIAL SYS*STIM 220 manufactured by Mettler Electronics Corp.
[45199598]
Patient Sequence No: 1, Text Type: N, H10
[45199599]
Patient set up on ifc (interferential current therapy) without incident. He stated he had no pain and was comfortable. Patient given a call light and encouraged to press call button if needing assistance during the 15 min. Treatment. Approximately 7 minutes into treatment, he felt the electrode was getting hot. No redness or blistering where electrodes had been. Electrodes were repositioned and therapy continued and was completed without obvious signs of injury. Patient sustained burn (2nd degree) to shoulder from an electrode during ifc treatment. He continues to treat the subsequent infection to the site. There was some conjecture that the patient used a topical pain ointment prescribed by md that may have impacted the conductivity of the electrodes. Equipment under analysis by manufacturer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5655572 |
| MDR Report Key | 5655572 |
| Date Received | 2016-05-16 |
| Date of Report | 2016-04-27 |
| Date of Event | 2016-03-23 |
| Report Date | 2016-04-26 |
| Date Reported to FDA | 2016-04-26 |
| Date Reported to Mfgr | 2016-04-26 |
| Date Added to Maude | 2016-05-16 |
| 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 | 2016-05-16 |
| Returned To Mfg | 2016-03-28 |
| Model Number | 220 |
| Device Availability | R |
| Device Age | 19 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | METTLER ELECTRONICS CORP |
| Manufacturer Address | 1333 S. CLAUDINA ST. ANAHEIM CA 92805 US 92805 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-05-16 |