MAUDE Adverse Event Report: POSEY PRODUCTS LLC 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

Evaluation results: a single wrist restraint was returned, this product is sold in pairs.The foam cuff at the end with box stitch and white hook is torn.All labels are present and legible.No loose or broken threads found.Upon evaluation of the torn foam cuff, the tear appears to have originated at the box stitch that secures the webbing to the foam.The box stitch is intact and the foam sewn with the box stitch has torn suggesting excessive force was applied resulting in the failure.It does not appear there was any other failure in the foam as the other box stitch area of the foam is intact.During the sewing process, the stitch needle perforates the foam when creating the box stitch, thus weakening the foam and a possible start point for a tear or rip when excessive force is applied.In regards to the complaint about the strap slipping, it is possible that the customer is not following step 5 of the instructions for use by twisting the strap 180 degrees during application.The instructions also advise the user to tie an overhand knot with the excess strap directly below the quick-release buckle to limit unwanted movement.This customer is new to posey soft limb holders and it is possible that on-site training, while typically performed for new customers, did not occur due to restrictions related to the covid-19 pandemic.Therefore, the apparent likely cause of the failure is use error or failure to follow instructions for application of the device.At this time, there is no evidence that a manufacturing defect contributed to the reported failure.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 "the foam is tearing when pts are pulling hard.Also the strap is slipping loose when pts are slightly pulling and working them from side to side.When this happens the nurse is tying them to the bed instead of using the proper technique which is no longer making the restraint a quick release." no gtin information is available.

• Brand Name: FOAM LIMB HOLDER
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): POSEY PRODUCTS LLC; 570 enterprise drive; neenah WI 54956
• Manufacturer Contact: chris rahn ; 570 enterprise dr; neenah, WI 54956 ; 9207514300
• MDR Report Key: 10896805
• MDR Text Key: 219164688
• Report Number: 2020362-2020-00131
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/30/2020

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: 0189T131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/30/2020
• Initial Date FDA Received: 11/24/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2020
• 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