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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: POSEY PRODUCTS LLC POSEY ECONOMY LIMB HOLDER RESTRAINT RESTRAINT, PROTECTIVE

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POSEY PRODUCTS LLC POSEY ECONOMY LIMB HOLDER RESTRAINT RESTRAINT, PROTECTIVE Back to Search Results
Catalog Number 2510
Device Problem Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/21/2021
Event Type  malfunction  
Event Description
Bilateral soft wrist restraints were placed on customer. Customer with periods of agitation, fight vent, kicking legs, grabbing at staff members and trying to shake it out. Restraint tore where the buckle attaches to the soft cloth. Immediate intervention to replace the broken/torn restraint with a new one was taken. No injury to patient or staff.
 
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Brand NamePOSEY ECONOMY LIMB HOLDER RESTRAINT
Type of DeviceRESTRAINT, PROTECTIVE
Manufacturer (Section D)
POSEY PRODUCTS LLC
272 east deerpath road
suite 206
lake forest IL 60045
MDR Report Key12568050
MDR Text Key274529050
Report Number12568050
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 09/30/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/04/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number2510
Device Lot Number1131T038
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/29/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/30/2021
Event Location Hospital
Date Report to Manufacturer10/04/2021
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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