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

Model Number 2510

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/23/2019

Event Type  malfunction  

Manufacturer Narrative

Upon visual inspection, the wrist restraint was damaged.The foam had torn where the d-ring is box stitched.The box stitch at the torn foam area remains intact.No evidence of any previous cuts or tears was observed.The box stitch joining the foam, wash label, and webbing containing the d-ring remained intact and did not fail.The failure of the product was in the foam.It appears that excessive force was applied by the patient causing the foam to tear.An attempt was performed and was successful in duplicating the observed failures.Based on the findings of the complaint recreation, the root cause for foam failure has been identified as the failure to follow the recommended ifu steps for application for use.The restraint was applied incorrectly.At this time, there is no evidence that a manufacturing non-conformity contributed to the reported complaint and the instructions for use (ifu) were reviewed and determined to provide adequate instructions and warning 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).

Event Description

Customer is reporting that a patient was able to get out of the restraint due to a tear in the product.Other holders in use have a tendency for potential slippage, this is the first one that ripped.No injuries occurred.Number on tag: (b)(4).

• Brand Name: 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: 9104081
• MDR Text Key: 201884538
• Report Number: 2020362-2019-00188
• 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: 09/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 2510
• Device Catalogue Number: 2510
• Device Lot Number: 9078T053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/05/2019
• Initial Date FDA Received: 09/23/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2019
• 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
• Patient Age: 51 YR