Brand Name | BROOKSTONE |
Type of Device | SHIATSU NECK AND BACK MASSAGER WITH HEAT |
Manufacturer (Section D) |
SHENZHEN FORREST HEALTH EQUIPMENTS CO., LTD |
403 east south building u |
jingtie technology industrial |
henggang, shenzhen guangdong 51800 0 |
CH 518000 |
|
MDR Report Key | 5634181 |
MDR Text Key | 44501058 |
Report Number | 1221298-2016-00001 |
Device Sequence Number | 1 |
Product Code |
ISA
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Distributor
|
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
04/13/2016 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Other
|
Device Model Number | 863806 |
Was Device Available for Evaluation? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 04/13/2016 |
Distributor Facility Aware Date | 12/28/2015 |
Event Location |
Home
|
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 05/05/2016 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
|
|