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

Model Number 2810

Device Problems Defective Device (2588); Material Split, Cut or Torn (4008)

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

Event Date 06/30/2022

Event Type  malfunction  

Event Description

At around 1630, found patient with contents (styrofoam balls/beads) of mitten all over her bed.Cleaned patient and notified manager of defective mitten.Mitten removed and new mitten placed on patient.Manufacturer response for posey mitt #2810, posey (per site reporter).Posey rep notified of at least 3 different instances where mitts have torn/broken, and beads were exposed.Pending follow-up, rep has also offered to provide alternative products.

• 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: 15445343
• MDR Text Key: 300163954
• Report Number: 15445343
• 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: 15330 DA
• Patient Sex: Female