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).
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