MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-17 for ALEVE DIRECT THERAPY PC90023 manufactured by Covidien.
[90772358]
An investigation is currently under way; upon completion the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
[90772359]
According to the reporter, during use, the device got hot and was smoking on one side of unit and charred the black corrugated pad and the gel pad. The patient was alive with no injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183164-2017-05003 |
| MDR Report Key | 6955911 |
| Date Received | 2017-10-17 |
| Date of Report | 2017-10-31 |
| Date of Event | 2017-10-06 |
| Date Mfgr Received | 2017-10-06 |
| Date Added to Maude | 2017-10-17 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | EDWARD ALMEIDA |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524151 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | 1313 W GRANT BLVD |
| Manufacturer City | WABASHA MN 55981 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55981 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ALEVE DIRECT THERAPY |
| Generic Name | STIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTER |
| Product Code | NUH |
| Date Received | 2017-10-17 |
| Model Number | PC90023 |
| Catalog Number | PC90023 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 1313 W GRANT BLVD WABASHA MN 55981 US 55981 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-17 |