Brand Name | BROOKSTONE |
Type of Device | NECK & SHOULDER SPORT MASSAGER WITH HEAT |
Manufacturer (Section D) |
DONGGUAN TAISHIN ELECTRONIC CO., LTD. |
no 140, liao-cha road |
lian-bian industrial park |
lia, dongguang guangdong 52340 3 |
CH 523403 |
|
MDR Report Key | 5670912 |
MDR Text Key | 45647458 |
Report Number | 1221298-2016-00005 |
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 |
05/20/2016 |
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 | 840018 |
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 05/20/2016 |
Distributor Facility Aware Date | 04/05/2016 |
Event Location |
Home
|
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 05/20/2016 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
|
|