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

Model Number 6546

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Customer reported the product does not have a secure hold.The customer did not provide a date when the issue was discovered.No patient incident or injury was reported.

Manufacturer Narrative

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

• Brand Name: EZ CLEAN GAIT BELT
• Manufacturer (Section D): J. T. POSEY CO.; arcadia CA
• Manufacturer Contact: roxana koussa ; 5635 peck rd.; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 4531590
• MDR Text Key: 16848033
• Report Number: 2020362-2015-00030
• 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: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/20/2015

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: Health Professional
• Device Model Number: 6546
• Device Catalogue Number: 6546
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/20/2015
• Initial Date FDA Received: 02/19/2015
• 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