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U.S. Department of Health and Human Services

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

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POSEY PRODUCTS, LLC POSEY ECONOMY LIMB HOLDER RESTRAINT, PROTECTIVE Back to Search Results
Device Problem Defective Device (2588)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/17/2020
Event Type  malfunction  
Event Description
Patient with traumatic brain injury had bilateral soft wrist restraints applied to prevent pulling at life sustaining tubes/lines. Nurse reported that the patient was agitated and ripped through the "economy limb holder. " the ring that holds the strap ripped off of the restraint allowing the patient to pull out an iv. The nurse was near to the patient at the time and was able to reach the patient before the patient could self-extubate. The iv was reinserted with no harm to the patient. The wrist restraint was bagged up and sent to the quality department.
 
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Brand NamePOSEY ECONOMY LIMB HOLDER
Type of DeviceRESTRAINT, PROTECTIVE
Manufacturer (Section D)
POSEY PRODUCTS, LLC
272 east deerpath road suite 206
lake forest IL 60045
MDR Report Key10167029
MDR Text Key195553476
Report Number10167029
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 06/17/2020,06/16/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/18/2020
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/17/2020
Event Location Hospital
Date Report to Manufacturer06/18/2020
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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