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

Model Number 2532

Device Problem Insufficient Information (3190)

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

Event Type  malfunction  

Manufacturer Narrative

Product expected, but not yet received.Therefore, this report is based on the information provided by the customer.The customer was contacted for more information, but limited information was provided.A historical review of the complaint database revealed similar complaints for this part number of unintended patient release.Of those returned, broken clips, excessive force, and/or wear and tear has contributed to the malfunction.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 cuff s 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 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).

Event Description

Customer states we had a patient incident where a patient was able to free themselves from new restraint.The product was item # 2532.Have limited additional information on this incident.No gtin or lot# inforamtion was avaialble.

Manufacturer Narrative

The actual complaint device was not returned.Other units from the same lot and units from other lots were received and evaluated.All products were unopened/unused and/or still sealed in the original packaging.Upon visual inspection of the returned products in their original packaging, no abnormalities were found.Two of the products from the complaint lot were opened to verify if they meet the manufacturing specifications.Both products were measured using the product drawing as a reference.Both products were found to meet specifications with no abnormalities observed.It appears that the customer lost confidence of using the limb holder products and returned all on-hand inventory.Instructions for use (ifu) were reviewed and found to provide adequate instructions and warnings for safe and effective use of the device.The dhr for complaint lot was reviewed and found no anomalies or discrepancies.A sampling of units passed all testing and there were no ncrs associated with this lot prior to release for distribution.Historical data found complaints of unintentional patient release for the foam limb holder (part 2532).Of those returned, broken clips, excessive force, and/or wear and tear has contributed to the malfunction.Other complaints of straps slipping or loosening could not be confirmed.Other similar complaints were determined to be due to improper application of the device or use with incorrect patient population per the product ifu.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.There are no further corrective actions required at this time.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

Supplemental report needed for additional information.

• Brand Name: FOAM LIMB HOLDER
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): POSEY PRODUCTS LLC; 2530 e lindsay privado dr; ste a; ontario CA 91761
• MDR Report Key: 11457973
• MDR Text Key: 250960283
• Report Number: 2020362-2021-00010
• Device Sequence Number: 1
• Product Code: FMQ
• Combination Product (y/n): N
• PMA/PMN Number: K963413
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 04/07/2021

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/08/2021
• Initial Date FDA Received: 03/10/2021
• Supplement Dates Manufacturer Received: 04/07/2021
• Supplement Dates FDA Received: 04/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1