MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-28 for TENS - SHOULDER THERAPY DEVICE manufactured by Unk.
[103983619]
Patient called to report an adverse event that took place while using a tens shoulder therapy device. Patient stated that as soon as her therapy started with the device, she blacked out and had heart failure. Patient stated she spent time in the icu and rehab and almost died.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5076210 |
| MDR Report Key | 7380897 |
| Date Received | 2018-03-28 |
| Date of Report | 2018-03-28 |
| Date Added to Maude | 2018-03-29 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 | TENS - SHOULDER THERAPY DEVICE |
| Generic Name | STIMULATOR, NERVE, TRANSCUTANEOUS |
| Product Code | NUH |
| Date Received | 2018-03-28 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2018-03-28 |