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

Model Number 2532

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Customer confirmed the product will not be returning for analysis.Therefore, this event is reported based on the information provided by the customer and from historical data of similar complaints.Historical data found similar complaints for the posey foam limb holder.Of those returned, broken buckles, excessive force and/or wear and tear has contributed to the malfunction.If the strap does not stay secured, or the strap or webbing tears while in use, it may allow the unintentional release of the patient.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 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 reported via email the holders are experiencing loosening and allowing patients to release straps.The date the issue was discovered is unknown and no patient incident or injury was reported.

• Brand Name: FOAM LIMB HOLDER
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): POSEY PRODUCT; 2530 lindsay privado drive; ontario CA 91761
• Manufacturer Contact: chris rahn ; 530 enterprise drive; neenah, WI 54956 ; 9207514300
• MDR Report Key: 10401794
• MDR Text Key: 203526524
• Report Number: 2020362-2020-00094
• 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: 07/14/2020

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/14/2020
• Initial Date FDA Received: 08/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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