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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TIDI PRODUCTS, LLC POSEY LIMB HOLDER UNIV D RING; RESTRAINT, PROTECTIVE
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TIDI PRODUCTS, LLC POSEY LIMB HOLDER UNIV D RING; RESTRAINT, PROTECTIVE Back to Search Results
Model Number 2551
Device Problem Break (1069)
Patient Problem Insufficient Information (4580)
Event Date 08/23/2022
Event Type  malfunction  
Event Description
Patient (alcohol withdrawal/delirium), on occasion has been aggressive with kicking, clenched fists, and sliding body in attempt to grab at endotracheal tube.Nurse was helping turn patient when nurse unclipped the soft wrist restraint on patient's left arm, the nurse found the restraint's clip to be broke.No harm to patient.The nurse promptly replaced the restraint with a new one.Restraints (left and right) were discontinued later the same day after having less agitation after being extubated only the vest restraint was continued.
 
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Brand Name
POSEY LIMB HOLDER UNIV D RING
Type of Device
RESTRAINT, PROTECTIVE
Manufacturer (Section D)
TIDI PRODUCTS, LLC
570 enterprise dr
neenah WI 54956
MDR Report Key15369702
MDR Text Key299393501
Report Number15369702
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 Other Health Care Professional
Type of Report Initial
Report Date 08/29/2022
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 Model Number2551
Device Catalogue Number2551
Device Lot Number2018T091
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/29/2022
Event Location Hospital
Date Report to Manufacturer09/07/2022
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/07/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age13505 DA
Patient SexMale
Patient Weight27 KG
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