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

Model Number 2551

Device Problem Device Slipped (1584)

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

Event Type  malfunction  

Manufacturer Narrative

Product was discarded and will not be returned.Therefore, this event is reported based on the information provided by the customer and from historical data of similar complaints.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.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).Product not returned.

Event Description

Customer contacted us via e-mail.The customer states "(b)(4) we had an issues with mfg # (b)(4)- in the email they said they tossed the malfunctioning restraints - they wanted me to report - do you have any other reported issues of this happening? we had another set of soft limb restraints malfunction last evening that almost resulted in the patient extubating themselves.They are slipping easily when the patient pulls at the restraint.(b)(4) and i advised the nurse to change out the restraints and toss the malfunctioning set due to this being a covid + room.I know we had some issues with this a few months ago and we just wanted to bring it to your attention again." i have limited other information available.No gtin or lot# was made available.A ts template has been completed and saved to the drive.I am unsure if we will be able to get product back for inspection due to customer comments.

• Brand Name: 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, WI 54956 ; 9207514300
• MDR Report Key: 11532020
• MDR Text Key: 242828482
• Report Number: 2020362-2021-00012
• 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: 02/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 2551
• Device Catalogue Number: 2551
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1