MAUDE Adverse Event Report: POSEY PRODUCTS, LLC MITTS - NO FINGER SEPARATORS; RESTRAINT, PROTECTIVE

Model Number 2810

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 08/27/2022

Event Type  malfunction  

Event Description

Patient bit through her posey mittens, sending beads everywhere in a patient that was at risk for aspiration.Packaging was not saved.This is a reported 3rd incidence (3 different instances) of tearing or breakage causing beads to be exposed to patient.Manufacturer response for mitt, posey mitt - green (per site reporter).Manufacturer representative from posey has responded to the concerns with use of the mitts.Pending additional response, but she is willing to provide alternative options.

• Brand Name: MITTS - NO FINGER SEPARATORS
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): POSEY PRODUCTS, LLC; 570 enterprise drive; neenah WI 54956
• MDR Report Key: 15445379
• MDR Text Key: 300132659
• Report Number: 15445379
• Device Sequence Number: 1
• Product Code: FMQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/08/2022

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: Lay User/Patient
• Device Model Number: 2810
• Device Catalogue Number: 2810
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/08/2022
• Event Location: Hospital
• Date Report to Manufacturer: 09/19/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/19/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 30660 DA
• Patient Sex: Female