MAUDE Adverse Event Report: TIDI PRODUCTS, LLC POSEY GAIT BELT; AID, TRANSFER

Model Number 6556

Device Problems Product Quality Problem (1506); Device Slipped (1584)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/14/2022

Event Type  malfunction  

Event Description

Occupational therapist working with patient using walker and gait belt in hallway stairs.Patient's knees buckled on stairs.Gait belt "slipped" and patient assisted to the ground.Gait belt evaluated and compared to other gait belts with same lot number and brand.Gait belt that slipped noted to be thinner.Suspected cause of "slipping" may be related to lack of belt thickness for material to grip against buckle teeth.

• Brand Name: POSEY GAIT BELT
• Type of Device: AID, TRANSFER
• Manufacturer (Section D): TIDI PRODUCTS, LLC; 272 east deerpath road; suite 206; lake forest IL 60045
• MDR Report Key: 14787011
• MDR Text Key: 294585653
• Report Number: 14787011
• Device Sequence Number: 1
• Product Code: IKX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/20/2022

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: Other
• Device Model Number: 6556
• Device Catalogue Number: 6556
• Device Lot Number: 2005T371
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/20/2022
• Event Location: Hospital
• Date Report to Manufacturer: 06/23/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/23/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 24455 DA
• Patient Weight: 112 KG