MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2015-10-27 for BMS3WT - MASSAGER manufactured by Conair Corporation.
[29323571]
The device is no longer sold and has not been supplied in the us for approximately 15 years. Within the past 20 years, this is the second alleged malfunction received for this product. Device not submitted to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[29323572]
Consumer alleges to have received 2nd degree burns from laying on the massager for her back, but she received the burn on her left hip back area. She claims to have received medical attention and that the er has given her pain medications and creams. She claims to have severe depression and anxiety from this incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222304-2015-00022 |
| MDR Report Key | 5180092 |
| Report Source | CONSUMER |
| Date Received | 2015-10-27 |
| Date of Report | 2015-10-08 |
| Date of Event | 2015-10-05 |
| Date Mfgr Received | 2015-10-08 |
| Date Added to Maude | 2015-10-27 |
| 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 Street | 1 CUMMINGS POINT RD |
| Manufacturer City | STAMFORD CT 06902 |
| Manufacturer Country | US |
| Manufacturer Postal | 06902 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BMS3WT - MASSAGER |
| Generic Name | MASSAGER |
| Product Code | ISA |
| Date Received | 2015-10-27 |
| Model Number | BMS3WT |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONAIR CORPORATION |
| Manufacturer Address | 1 CUMMINGS POINT RD STAMFORD CT 06902 US 06902 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-10-27 |