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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: POSEY COMPANY LIMB HOLDER RESTRAINT, PROTECTIVE

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POSEY COMPANY LIMB HOLDER RESTRAINT, PROTECTIVE Back to Search Results
Model Number 2550
Device Problem Torn Material (3024)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Evaluation codes: evaluation of the returned device found the soft limb restraints are non functional and will not perform as intended. Both limb holders have the box stitches coming apart most likely due to excessive force as indicated in the reported issue. One limb restraint appeared to have been cut by a sharp object as the webbing does not show signs of tensile/pull failure. Note: the instructions for use (ifu) states "limb holder for limiting limb movement only. Do not use on a patient who is or becomes highly aggressive, combative, agitated, or suicidal. Additional or different body or limb restraints may be needed if the patient pulls violently against the bed straps. " manufacturer reference file #(b)(4).
 
Event Description
Customer reported the patient pulled and was able to tear away from the connecting strap. The second time the restraint was applied to the patient, while on the gurney the patient was able to fray and tear the restraint by applying enough resistance. The date the issue was discovered is unknown and no injuries were reported. The patient was being monitored at the time of the event.
 
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Brand NameLIMB HOLDER
Type of DeviceRESTRAINT, PROTECTIVE
Manufacturer (Section D)
POSEY COMPANY
5635 peck road
arcadia CA 91006
Manufacturer (Section G)
POSEY S DE RL DE CV
cam.antigua a tecate #16760
colonia ninos heroes este
tijuana, baja california 22120
MX 22120
Manufacturer Contact
william hincy
posey company
5635 peck road
arcadia, CA 91006
6264433143
MDR Report Key6614218
MDR Text Key76955572
Report Number2020362-2017-00025
Device Sequence Number1
Product Code FMQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K963413
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial
Report Date 05/11/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/06/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2550
Device Catalogue Number2550
Device Lot Number7103T045
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/11/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/13/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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