MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-05 for ACCURELIEF WIRELESS 3-IN-1 PAIN RELIEF DEVICE ACRL-9100 NA manufactured by Compass Health Brands.
[138085404]
Attached tens otc unit to my back as usual and powered it on. Received a painful, stunning shock. Unit wouldn? T power off and i couldn? T remove it myself due to muscle spasms, until the device spontaneously changed to an intermittent mode. The intensity setting was at 1, the lowest level. Device: accurelief acrl-9100, compass health brands, carex health brands lot: sz1510799. Pad exp 31/05/2020.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5084660 |
| MDR Report Key | 8394098 |
| Date Received | 2019-03-05 |
| Date of Report | 2019-03-02 |
| Date of Event | 2019-03-02 |
| Date Added to Maude | 2019-03-06 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| 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 | ACCURELIEF WIRELESS 3-IN-1 PAIN RELIEF DEVICE |
| Generic Name | STIMULATOR, MUSCLE, POWERED |
| Product Code | IPF |
| Date Received | 2019-03-05 |
| Model Number | ACRL-9100 |
| Catalog Number | NA |
| Lot Number | SZ1510799 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COMPASS HEALTH BRANDS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-05 |