MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-28 for OMNISTIM ELECTROTHERAPY ELECTRODE 61227 manufactured by Accelerated Care Plus.
[181771908]
During electrical slim treatment resident complained of pain at electrode site. Treatment stopped, area inspected. Found electrode wire had separated from gel pad. Skin inspected and found to have 1. 5" inner-shaped burn to thigh. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093393 |
| MDR Report Key | 9774524 |
| Date Received | 2020-02-28 |
| Date of Report | 2020-02-26 |
| Date of Event | 2020-02-17 |
| Date Added to Maude | 2020-03-02 |
| 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 | 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 | OMNISTIM ELECTROTHERAPY ELECTRODE |
| Generic Name | STIMULATOR, MUSCLE, POWERED |
| Product Code | IPF |
| Date Received | 2020-02-28 |
| Catalog Number | 61227 |
| Lot Number | Y113018-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACCELERATED CARE PLUS |
| Manufacturer Address | RENO NV 89502 US 89502 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2020-02-28 |