MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-26 for DRIVEMEDICAL AGF-3X manufactured by Medical Depot, Inc..
[180885255]
Patient states she was prescribed a tens unit for her broken back that caused severe sciatic nerve damage. She reports she was laying down with the machine patches on her outer right thigh when a live wire came out of a patch. Where the live wire touched her outer right buttock, it left a burn. She reports the battery part does not work properly. The vibration and pulse works some of the time as dialed then goes very low or does not work at all. Our medical supply office believes the patient was not using this appropriately as the lead wires were loose to the electrodes. We believe she pulled the electrodes off with the lead wires causing the wire to be exposed instead of peeling them off. Our employee showed the patient that the lead wires and the electrodes needed to be intake before using (it appeared they were pulled on and loose which could have caused the wire to be exposed). She also reviewed the instruction booklet with the patient and asked her to f/u with her physician.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9753572 |
| MDR Report Key | 9753572 |
| Date Received | 2020-02-26 |
| Date of Report | 2020-01-29 |
| Date of Event | 2020-01-21 |
| Report Date | 2020-01-29 |
| Date Reported to FDA | 2020-01-29 |
| Date Reported to Mfgr | 2020-02-26 |
| Date Added to Maude | 2020-02-26 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 | DRIVEMEDICAL |
| Generic Name | ELECTRODE, CUTANEOUS |
| Product Code | GXY |
| Date Received | 2020-02-26 |
| Model Number | AGF-3X |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDICAL DEPOT, INC. |
| Manufacturer Address | 99 SEAVIEW BLVD PORT WASHINGTON NY 11050 US 11050 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-26 |