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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: POSEY PRODUCTS LLC POSEY SAFETY VEST RESTRAINT, PROTECTIVE

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POSEY PRODUCTS LLC POSEY SAFETY VEST RESTRAINT, PROTECTIVE Back to Search Results
Catalog Number 3050XL
Device Problem Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/06/2021
Event Type  malfunction  
Event Description
Young male patient with behavioral issues in a roll vest to maintain safety, patient impulsive and sits up in bed, pushes self up, pulling at lines. Patient had aggressive attempts to get out of bed during outbursts of agitation throughout the night. Patient ripped the seam of the vest restraint. Nurse was present in a room and heard a ripping noise. Knowing they had a patient in next room in restraints, the nurse asked another to go check on the patient. Patient managed to rip only a small area before staff intervened. No injuries or other issues noted. Restraint was applied on admission date (2 days prior to event).
 
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Brand NamePOSEY SAFETY VEST
Type of DeviceRESTRAINT, PROTECTIVE
Manufacturer (Section D)
POSEY PRODUCTS LLC
272 east deerpath road suite 206
lake forest IL 60045
MDR Report Key11677621
MDR Text Key245808258
Report Number11677621
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
Report Date 04/09/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number3050XL
Device Lot Number1026T030
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/09/2021
Event Location Hospital
Date Report to Manufacturer04/16/2021
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?
Type of Device Usage Unkown

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