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 08/24/2022

Event Type  malfunction  

Event Description

Patient was fitted with newly implemented posey mitts #2810.Patient clawed her way through the mittens from the inside out, sending the tiny beads inside of them all over the patient and onto the floor.Manufacturer response for mitt, (brand not provided) (per site reporter).Posey rep has been in contact with our hospital.Pending further response or instruction, but did offer to provide alternative products to replace green mitt.

• 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: 15445344
• MDR Text Key: 300163983
• Report Number: 15445344
• 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 Model Number: 2810
• Device Catalogue Number: 2810
• 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: 31755 DA
• Patient Sex: Female