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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: POSEY PRODUCTS LLC POSEY LEATHER LOCK RESTRAINT POSY LEATHER LOCK RESTRAINT

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POSEY PRODUCTS LLC POSEY LEATHER LOCK RESTRAINT POSY LEATHER LOCK RESTRAINT Back to Search Results
Device Problem Defective Device (2588)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/28/2017
Event Type  Injury  
Event Description
Defective leather locked restraint could not be unlocked. Required intervention to remove.
 
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Brand NamePOSEY LEATHER LOCK RESTRAINT
Type of DevicePOSY LEATHER LOCK RESTRAINT
Manufacturer (Section D)
POSEY PRODUCTS LLC
MDR Report Key6543711
MDR Text Key74548904
Report NumberMW5069561
Device Sequence Number1
Product Code FMQ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/02/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/02/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
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

Patient Treatment Data
Date Received: 05/02/2017 Patient Sequence Number: 1
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