MAUDE Adverse Event Report: POSEY, S. DE R.L. DE C.V. GAIT BELT; RESTRAINT, PROTECTIVE

Lot Number 9253T070

Device Problem Device Slipped (1584)

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

Event Date 11/26/2019

Event Type  malfunction  

Event Description

Two new gait belts.Multiple staff reporting that the buckle/clasp slips and fails to hold the patient securely when under tension.

• Brand Name: GAIT BELT
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): POSEY, S. DE R.L. DE C.V.; 272 east deerpath road; suite 206; lake forest IL 60045
• MDR Report Key: 9738902
• MDR Text Key: 180398165
• Report Number: 9738902
• 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: 12/03/2019,12/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 9253T070
• 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: 12/03/2019
• Date Report to Manufacturer: 02/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1