MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2018-11-21 for ALEVE DIRECT THERAPY TENS manufactured by Bayer Healthcare Llc, Consumer Care.
[128255685]
This spontaneous case was reported by a consumer and describes the occurrence of device material issue ("i think it got hot or warm, i'm not sure") in an adult male patient who received aleve tens device direct therapy unit for pain. On an unknown date, the patient started aleve tens device direct therapy unit. On an unknown date, the patient noticed device material issue (seriousness criteria medically significant). It was unknown whether any action was taken with aleve tens device direct therapy unit. At the time of the report, the device material issue outcome was unknown. The reporter provided no causality assessment for device material issue with aleve tens device direct therapy unit. Further company follow-up with the consumer is not possible. Most recent follow-up information incorporated above includes: on 14-nov-2018: upon internal review of information originally received on 14-nov-2018. The event of i think it got hot or warm, i'm not sure was upgraded to incident event. Device material issue is listed according aleve tens device direct therapy unit and related to the device due to formal reasons. At the time of reporting, there is no evidence that a device-related defect or malfunction caused a death or serious injury. However there was a potential for harm to the patient if the device issue happened while it was attached to the skin. This case was regarded as incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2248903-2018-00006 |
| MDR Report Key | 8094646 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2018-11-21 |
| Date of Report | 2018-12-04 |
| Date Mfgr Received | 2018-11-30 |
| Date Added to Maude | 2018-11-21 |
| 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 | K SHAW LAMBERSON |
| Manufacturer Street | 100 BAYER BLVD. P.O. BOX 915 |
| Manufacturer City | WHIPPANY NJ 079810915 |
| Manufacturer Country | US |
| Manufacturer Postal | 079810915 |
| Manufacturer G1 | BAYER HEALTHCARE LLC, CONSUMER CARE |
| Manufacturer Street | 36 COLUMBIA RD. |
| Manufacturer City | MORRISTOWN NJ 07960 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07960 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALEVE DIRECT THERAPY TENS |
| Generic Name | STIMULATOR, NERVE, TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR (TENS), |
| Product Code | NUH |
| Date Received | 2018-11-21 |
| Model Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAYER HEALTHCARE LLC, CONSUMER CARE |
| Manufacturer Address | 36 COLUMBIA RD. MORRISTOWN NJ 07960 US 07960 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2018-11-21 |