MAUDE Adverse Event Report: J. T. POSEY CO. EZ CLEAN GAIT BELT SPRING - LOADED

Model Number 6546Y

Device Problem Device Issue (2379)

Patient Problems Fall (1848); No Known Impact Or Consequence To Patient (2692)

Event Date 09/18/2014

Event Type  malfunction  

Manufacturer Narrative

Product was requested to be returned for evaluation and has not been received.(b)(4).

Event Description

Customer reported that there was a patient fall.A patient with a below knee amputation standing with a recliner behind him (which is locked) moved away from him, but the gait belt moves superiorly on the patient.The therapist is unable to readjust the belt due to buckle mechanism, she is not able to manipulate the patient and belt to move the patient to safety.

• Brand Name: EZ CLEAN GAIT BELT SPRING - LOADED
• Manufacturer (Section D): J. T. POSEY CO.; arcadia CA
• Manufacturer Contact: mary segura ; 5635 peck rd.; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 4187963
• MDR Text Key: 19369563
• Report Number: 2020362-2014-00339
• Device Sequence Number: 1
• Product Code: IKX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6546Y
• Device Catalogue Number: 6546Y
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1