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

Model Number 2532

Device Problem Positioning Problem (3009)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/07/2021

Event Type  malfunction  

Manufacturer Narrative

Device was discarded and is not available for evaluation.Therefore, this report is based solely on the information provided by the customer.The customer was contacted for more information, but limited information was provided.The customer has been trained on proper application of the device.When contacted for more information regarding this complaint, the customer reported that the issue is resolved and is no longer having issues.The customer has transitioned to using a different product since this complaint was received.Manufacturing investigation and documentation review found no nonconformances or anomalies related to the lot number associated with this complaint, units passed testing prior to release for distribution.Samples were pulled from inventory and tested and those samples met pull force requirements per product design history file.A historical review of the complaint database revealed similar complaints for this part number of unintended patient release over the last 2 years.Of those returned, broken clips, excessive force, and/or wear and tear has contributed to the malfunction.Additionally, user error related to misapplication of the device per the instructions for use or use with incorrect patient population were found to have contributed to several such complaints.There were several complaints received for straps slipping which were determined to be due to manufacturing issues that have been addressed via the capa system, however this does not relate to this complaint based on the event description.Instructions for use (ifu) were reviewed and found to provide adequate instructions and warnings for safe and effective use of the device.The ifu states to before each use, check cuffs and straps for cracks, tears, and/or excessive wear or stretch, broken buckles or locks, and/or that hook-and-loop adheres securely as these may allow patient to remove cuff.Discard if device is damaged or if unable to lock.The ifu also provided extra warning to 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.Without return of the device the reported issue could not be confirmed.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 further 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

This is from a 45 day letter from fda received by email and march 7, 2021.Posey restraint is easily removed/unclamped by the patient.The straps are very thin.No other information is given on the form.

• Brand Name: FOAM LIMB HOLDER
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): POSEY PRODUCTS LLC; 570 enterrprise drive; neenah WI 54956
• Manufacturer Contact: chris rahn ; 570 enterprise dr; neenah, WI 54956 ; 6082193923
• MDR Report Key: 11633501
• MDR Text Key: 250240454
• Report Number: 2020362-2021-00016
• 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: 03/08/2021

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: 0302T394
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/08/2021
• Initial Date FDA Received: 04/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2020
• 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
• Patient Age: 60 YR