MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-04 for QUELL PAIN RELIEF manufactured by Neurometrix.
[61614279]
I began using the quell pain relief electrode band yesterday. I noticed some pain in my knee that i never had before. Today i had add'l pain in my shin. The pain occurred on the leg near where i wore the band. I stopped wearing the device and hope the pain will disappear completely soon. The pain is not bad, but definitely there.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5066545 |
| MDR Report Key | 6147520 |
| Date Received | 2016-12-04 |
| Date of Report | 2016-12-04 |
| Date of Event | 2016-12-04 |
| Date Added to Maude | 2016-12-06 |
| 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 | 0 |
| Brand Name | QUELL PAIN RELIEF |
| Generic Name | NERVE STIMULATOR |
| Product Code | NUH |
| Date Received | 2016-12-04 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEUROMETRIX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-12-04 |