MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-05 for BROOKSTONE 882101 manufactured by Shenzhen Jinyuan Sports Massager Instrument Co.,lt.
[44499617]
Customer alleges that she suffered a burn on her back after use of device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221298-2016-00003 |
| MDR Report Key | 5634304 |
| Date Received | 2016-05-05 |
| Date of Report | 2016-04-13 |
| Date of Event | 2015-10-22 |
| Date Facility Aware | 2016-01-08 |
| Report Date | 2016-04-13 |
| Date Reported to FDA | 2016-04-13 |
| Date Added to Maude | 2016-05-05 |
| 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 | SHIATSU 3D LUMBAR MASSAGER WITH HEAT |
| Product Code | ISA |
| Date Received | 2016-05-05 |
| Model Number | 882101 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SHENZHEN JINYUAN SPORTS MASSAGER INSTRUMENT CO.,LT |
| Manufacturer Address | NO 2A BUILDING, SIXTH INDUSTRY GONGMING TOWN, BAOAN DISTRICT SHENZHEN, SHENZHEN GUANGDONG 518106 CH 518106 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-05-05 |