MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-05 for BROOKSTONE 863806 manufactured by Shenzhen Forrest Health Equipments Co., Ltd.
[44497498]
Customer lodged a complaint via importer's call center alleging that an elderly woman suffered a fractured vertebrae after use of device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221298-2016-00004 |
| MDR Report Key | 5634180 |
| Date Received | 2016-05-05 |
| Date of Report | 2016-04-13 |
| Date of Event | 2013-12-01 |
| Date Facility Aware | 2015-05-12 |
| 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 NECK AND BACK MASSAGER WITH HEAT |
| Product Code | ISA |
| Date Received | 2016-05-05 |
| Model Number | 863806 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SHENZHEN FORREST HEALTH EQUIPMENTS CO., LTD |
| Manufacturer Address | 403 EAST AND SOUTH BUILDING JINGTIE TECHNOLOGY INDUSTRIAL HENGGANG, SHENZHEN GUANGDONG 518000 CH 518000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-05-05 |