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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: POSEY COMPANY FOAM LIMB HOLDER RESTRAINT, PROTECTIVE

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POSEY COMPANY FOAM LIMB HOLDER RESTRAINT, PROTECTIVE Back to Search Results
Model Number 2532
Device Problems Improper or Incorrect Procedure or Method (2017); Device Handling Problem (3265)
Patient Problems Fall (1848); Anxiety (2328)
Event Date 03/21/2017
Event Type  malfunction  
Event Description
Patient broke soft wrist restraint and flung self over bedrail onto floor on other side of bed. Came into ed agitated after self-harm. Leather restraints applied. Decision to intubate for agitation and testing. Leathers discontinued and soft wrist restraints applied for medical protection of tubes. During extubation, patient broke plastic piece on one wrist restraint, swung over to the other side of bed and flipped over side rail, landing on floor.
 
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Brand NameFOAM LIMB HOLDER
Type of DeviceRESTRAINT, PROTECTIVE
Manufacturer (Section D)
POSEY COMPANY
arcadia CA 91006
MDR Report Key6427187
MDR Text Key70689505
Report NumberMW5068579
Device Sequence Number1
Product Code FMQ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 03/21/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/21/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2532
Device Lot Number7032T043
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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