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U.S. Department of Health and Human Services

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

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POSEY COMPANY FOAM LIMB HOLDER RESTRAINT, PROTECTIVE Back to Search Results
Model Number 2520
Device Problem Torn Material (3024)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Evaluation of the returned foam limb holder pair found the foam material is dirty and is coming apart at the wrist strap box stitch. The apparent cause is excessive force however a root cause is being investigated. The instructions for use were reviewed and found to provide adequate instructions and warnings for safe and effective use of the device. (b)(4).
 
Event Description
Customer reported while the restraint was in use with the patient, the material that the strap is attached to tore. As a result, the patient was able to break free of the restraint and pull out their endotracheal tube. No serious injuries were reported.
 
Manufacturer Narrative
Conclusion: the reported malfunction was confirmed. The tear on both foam cuffs started where the box stitch is applied, which secures the strap. Further observation revealed the tensile forces applied onto the strap appeared to have transferred to the box stitch on the foam cuff. The tensile force applied was greater than the strength of the foam and not the box stitch. A sample was removed from inventory to duplicate the failure experienced by the returned products. Both restraints were secured to the wrist and the secure straps to the leg on a table. Tensile force was applied to the restraint causing tension on the straps, no tear was experienced. Additional force was applied which caused the foam cuff to tear in the same area as the returned products. The failure was able to be duplicated. There have been extensive attempts to request additional information concerning the patient during the incident. There have been no responses to the inquiries; therefore, it is unknown whether or not there was an injury during this incident. A review of the ifu contains contraindications stating, "do not use on a patient who is or becomes highly aggressive, combative, agitated, or suicidal". At this time, with only the information available, the root cause of the reported issue cannot be determined. All complaints are trended and reviewed by management on a monthly basis. As a part of the monthly review, any excursion above the control limits for this failure mode will be assessed, documented and acted upon as warranted. No corrective or preventative actions are necessary at this time. Manufacturer reference file #(b)(4).
 
Event Description
Supplemental is required for additional investigation results.
 
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Brand NameFOAM LIMB HOLDER
Type of DeviceRESTRAINT, PROTECTIVE
Manufacturer (Section D)
POSEY COMPANY
5635 peck rd.
arcadia CA 91006
Manufacturer (Section G)
POSEY, S. DE R.L. DE C.V.
ave. ferrocarril no. 16901. bo
colonia rio tijuana, 3ra. etap
tijuana, mexico
Manufacturer Contact
william hincy
posey company
5635 peck road
arcadia, CA 91006
6264433143
MDR Report Key6562361
MDR Text Key75147105
Report Number2020362-2017-00014
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 health professional,user faci
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/08/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/11/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2520
Device Catalogue Number2520
Device Lot Number6342T032
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/01/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/13/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/08/2016
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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