Brand Name | POSEY |
Type of Device | RESTRAINT, PROTECTIVE |
Manufacturer (Section D) |
TIDI PRODUCTS |
570 enterprise dr |
neenah WI 54956 |
|
MDR Report Key | 11421299 |
MDR Text Key | 234927537 |
Report Number | 11421299 |
Device Sequence Number | 1 |
Product Code |
FMQ
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Type of Report
| Initial,Followup |
Report Date |
02/23/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
No Information
|
Device Lot Number | 0302T394 |
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 02/23/2021 |
Date Report to Manufacturer | 03/05/2021 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 03/05/2021 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 03/10/2021
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Age | 21830 DA |
|
|