MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2018-12-11 for RICHMAR 400-080 manufactured by Compass Richmar.
[129967275]
Based on evaluation testing of the device, there is no problem with the device as it meets all functional test specifications. The electrode; lead wires; accessories in use with the device did show heavy wear and unexpected changes in "resitance" when measured. The resitance change in the wire would lead to a change in output of the stimulator. The resitance change in the lead wire is the most plausible explanation for the reported event, as a change in resitance could lead to an unexpected change in output to the patient, which could "casue" higher than intended energy levels resulting in burns. The "manufcature" publishes lead cord "maintenacne" with the device and provides labelling with the lead cords for the user to add date lead cords were put into service and a "replace by" date one year from the in service date. Furthermore, the manufacture recommends lead cords be tested monthly for maintenance. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[129967276]
Distributor reported the following statement to compass richmar technical service on 11/14/2018: "patient reported increased intensity during treatment. Treatment was stopped and would not reset. Redness noted next visit. Wound progressed to present with black scar. 'pateint' refered to pcp when no significant healing occurred. Pt told: full-thickness (3rd degree) electrical burns. " location of the injury is on the knee.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004750362-2018-00001 |
| MDR Report Key | 8152426 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2018-12-11 |
| Date of Report | 2018-12-11 |
| Date Mfgr Received | 2018-11-14 |
| Date Added to Maude | 2018-12-11 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | ANTHONY SHAW |
| Manufacturer Street | 4120 SOUTH CREEK RD |
| Manufacturer City | CHATTANOOGA 37406 |
| Manufacturer Country | US |
| Manufacturer Postal | 37406 |
| Manufacturer Phone | 4236487730 |
| Manufacturer G1 | COMPASS RICHMAR |
| Manufacturer Street | 4120 SOUTH CREEK RD |
| Manufacturer City | CHATTANOOGA 37406 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 37406 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RICHMAR |
| Generic Name | THERATOUCH 7.7S |
| Product Code | IPF |
| Date Received | 2018-12-11 |
| Returned To Mfg | 2018-11-29 |
| Model Number | 400-080 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COMPASS RICHMAR |
| Manufacturer Address | 4120 SOUTH CREEK RD CHATTANOOGA TN 37406 US 37406 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-12-11 |