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

Model Number 2534

Device Problem Device Slipped (1584)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Customer declined to return device.There have been no other complaints received for this part number.However, historical data found complaints for other foam limb holders.Of those returned, excessive force and/or wear and tear has contributed to the malfunction.These restraints are for limiting limb movement only and are not recommended for patients who are or who become highly aggressive, combative, agitated, or suicidal.The instructions for use (ifu) were reviewed and found to provide adequate instructions and warnings for safe and effective use of the device.It is recommended that the restraint not be used on patient who is or becomes highly aggressive, combative, agitated or suicidal.The ifu also provided extra warning to "always monitor patient per facility policy.Be aware that constant monitoring may be required for: aggressive or agitated patients; and patients deemed at risk of aspirating their vomit.This includes patients in the supine position, or who are not able to sit up.If the patient vomits, he or she could aspirate the vomit and suffocate.Be prepared to intervene at the first sign of danger.Such patients require frequent review and evaluation of their physical and psychological status." without return of the device the reported issue could not be confirmed and without the device lot information the release documentation could not be reviewed.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.Manufacturer reference file # (b)(4).Device not returned by customer.

Event Description

Territory manager informed us of customer's complaint for item 2534.The adjustable strap was able to be loosened, allowing the patient to grab at tubes.The date of the event is unknown and no injuries have been reported.

• Brand Name: POSEY QR FOAM LIMB HOLDER
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): POSEY PRODUCTS LLC; 5635 peck road; arcadia 91006
• Manufacturer Contact: chris rahn ; 5635 peck road; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 9188279
• MDR Text Key: 162944742
• Report Number: 2020362-2019-00192
• 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: company representative,user f
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 2534
• Device Catalogue Number: 2534
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/18/2019
• Initial Date FDA Received: 10/14/2019
• 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