MAUDE Adverse Event Report: POSEY PRODUCTS LLC PEEK A BOO MITTS; RESTRAINT, PROTECTIVE

Catalog Number 2811

Device Problem Protective Measures Problem (3015)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/28/2019

Event Type  malfunction  

Event Description

We have had 15 unplanned extubations over the past year where the root cause involved patient's being able to remove their mitts and self-extubate.We have also noted that patients were able to remove their mitts and remove other devices (keo-feeds, chest-tubes).

• Brand Name: PEEK A BOO MITTS
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): POSEY PRODUCTS LLC; tidi products, llc; 272 east deerpath road, ste 206; lake forest IL 60045
• MDR Report Key: 8381436
• MDR Text Key: 137510223
• Report Number: 8381436
• 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: 02/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 2811
• Device Lot Number: 8212T001
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/28/2019
• Date Report to Manufacturer: 03/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1