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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: POSEY, S. DE R.L. DE C.V. GAIT BELT RESTRAINT, PROTECTIVE

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POSEY, S. DE R.L. DE C.V. GAIT BELT RESTRAINT, PROTECTIVE Back to Search Results
Lot Number 9253T070
Device Problem Device Slipped (1584)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/26/2019
Event Type  malfunction  
Event Description
Two new gait belts. Multiple staff reporting that the buckle/clasp slips and fails to hold the patient securely when under tension.
 
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Brand NameGAIT BELT
Type of DeviceRESTRAINT, PROTECTIVE
Manufacturer (Section D)
POSEY, S. DE R.L. DE C.V.
272 east deerpath road
suite 206
lake forest IL 60045
MDR Report Key9738902
MDR Text Key180398165
Report Number9738902
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 12/03/2019,12/02/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number9253T070
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/03/2019
Event Location No Information
Date Report to Manufacturer02/21/2020
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

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