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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TIDI PRODUCTS POSEY RESTRAINT, PROTECTIVE

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TIDI PRODUCTS POSEY RESTRAINT, PROTECTIVE Back to Search Results
Lot Number 0302T394
Device Problems Inadequacy of Device Shape and/or Size (1583); Defective Component (2292); Material Integrity Problem (2978)
Patient Problem Insufficient Information (4580)
Event Date 01/07/2021
Event Type  malfunction  
Event Description
The posey restraint is easily removed/unclamped by the patient. The straps are very thin.
 
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Brand NamePOSEY
Type of DeviceRESTRAINT, PROTECTIVE
Manufacturer (Section D)
TIDI PRODUCTS
570 enterprise dr
neenah WI 54956
MDR Report Key11421299
MDR Text Key234927537
Report Number11421299
Device Sequence Number1
Product Code FMQ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial,Followup
Report Date 02/23/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/05/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number0302T394
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/23/2021
Event Location No Information
Date Report to Manufacturer03/05/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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