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

Model Number 2532

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Visual findings observed creases on the bed connecting strap, and the foam material and all labeling have been soiled.The rear end of the male buckle component for the bed connecting strap is broken.Evaluation of unit found the rear end of the male buckle component for the bed connecting strap is broken.The broken areas on both sides of the buckle do not have voids that would suggest a manufacturing issue contributed to the reported issue.Creases observed on the bed connecting strap indicating excessive force was applied.The customer reported that this particular patient was confused and combative which increased his risk for injury.The ifu states on the contraindications, do not use this device with someone who has continued highly aggressive or combative behavior, self-destructive behavior, or deemed to be an immediate risk to others or to self.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.The instructions for use (ifu) were reviewed and found to provide adequate instructions and warnings for safe and effective use of the device.No corrective or preventative actions are necessary at this time.Manufacturer reference file# (b)(4).

Event Description

Customer contacted us via e-mail.Customer states a patient in tsicu was wearing this bilateral wrist and the plastic buckle on the release broke and patient had free range to move his arm.No injury occurred to the patient, however, rn's are concerned if this is a problem or a defect with this type of restraint.Another concern expressed by the rn's was when they wanted to release the restraint it was difficult because it was behind the side rail.This particular patient was confused and combative, which increased his risk for injury and to the rn as well.No gtin information is available.Ts template has been completed and saved to the drive.The date the issue was discovered is unknown and no patient incident or injury was reported.

• Brand Name: FOAM LIMB HOLDER
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): POSEY PRODUCT; 2530 lindsay privado drive; unit a; ontario CA 91761
• Manufacturer Contact: chris rahn ; 570 enterprise dr; neenah, CA 54956 ; 9207514300
• MDR Report Key: 10743415
• MDR Text Key: 213464479
• Report Number: 2020362-2020-00121
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/29/2020

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?: Yes
• Device Operator: No Information
• Device Model Number: 2532
• Device Catalogue Number: 2532
• Device Lot Number: 0210T071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/29/2020
• Initial Date FDA Received: 10/27/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2020
• 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