MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-20 for BROOKSTONE 840018 manufactured by Dongguan Taishin Electronic Co., Ltd..
[45647458]
Customer alleges that he suffered a burn on her back after use of device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221298-2016-00005 |
| MDR Report Key | 5670912 |
| Date Received | 2016-05-20 |
| Date of Report | 2016-05-20 |
| Date of Event | 2016-03-29 |
| Date Facility Aware | 2016-04-05 |
| Report Date | 2016-05-20 |
| Date Reported to FDA | 2016-05-20 |
| Date Added to Maude | 2016-05-20 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BROOKSTONE |
| Generic Name | NECK & SHOULDER SPORT MASSAGER WITH HEAT |
| Product Code | ISA |
| Date Received | 2016-05-20 |
| Model Number | 840018 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DONGGUAN TAISHIN ELECTRONIC CO., LTD. |
| Manufacturer Address | NO 140, LIAO-CHA ROAD LIAN-BIAN INDUSTRIAL PARK LIA, DONGGUANG GUANGDONG 523403 CH 523403 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-05-20 |