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

Model Number 2532

Device Problem Stretched (1601)

Patient Problem Confusion/ Disorientation (2553)

Event Date 05/30/2017

Event Type  malfunction  

Manufacturer Narrative

(other): product was discarded by the customer and is not available for return.The customer had been compiling a list of incidents related to the soft limb holder as justification to upper management to consider switching to an alternative restraint.The customer is fully aware that the restraint is being used outside of the recommended instructions for use and thus decided not to report individual incidents to posey.Posey became aware by accident because the hospital forwarded the list of issues to a posey representative.This is a soft foam limb holder for limiting limb movement.It is contraindicated for the 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; to reduce the risk of the patient getting access to the line/wound/tube site; to prevent the patient from flailing or bucking up and down causing self-injury.A restraint must only be used in accord with the patient¿s individualized care plan (icp).Just as patient behavior is not 100% predictable, no product is 100% fool-proof.Patient safety requires regular reassessment and monitoring per facility policy.A product that worked in the past may be inappropriate if the patient¿s mental or physical health status changes.Never apply any product that you feel is unsafe.Consult with the proper medical authority if you have questions about patient safety.The patient was diagnosed with confusion and there was no patient injury reported.The reported issue of the strap stretching could not be confirmed because the product was not returned.At this time there is no evidence that a manufacturing non-conformity contributed to the reported complaint, and the instructions for use were reviewed and determined to provide adequate instructions and warnings for the safe and effective use of the device.Therefore, no corrective or preventative actions are necessary.All complaints are trended and reviewed by management on a monthly basis.As part of this monthly review, any excursion above the control limits for this failure mode will be assessed, documented and acted upon as warranted.(b)(4).Device discarded.

Event Description

Customer reported the limb holder clip strap stretched.Patient was diagnosed with confusion.There was no patient injury reported.

• Brand Name: FOAM LIMB HOLDER
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): POSEY PRODUCTS LLC; 5635 peck rd; arcadia CA 91006
• Manufacturer Contact: william hincy ; posey company; 5635 peck road; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 6699290
• MDR Text Key: 79771713
• Report Number: 2020362-2017-00038
• Device Sequence Number: 1
• Product Code: FMQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K963413
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 2532
• Device Catalogue Number: 2532
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1