MAUDE Adverse Event Report: J. T. POSEY CO. DELUXE WALKING TRANSFER BELT W/QR

Model Number 6537QDX

Device Problem Device Issue (2379)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Customer reported while the walking belt is in use the strap in front loosens causing the belt to slide down.The date the issue was discovered was not provided.No patient incident or injury was reported.

Manufacturer Narrative

Product was requested to be returned for evaluation and has not been received.Note: this report is submitted based on the customers initial reported issue.(b)(4).

• Brand Name: DELUXE WALKING TRANSFER BELT W/QR
• Manufacturer (Section D): J. T. POSEY CO.; arcadia CA
• Manufacturer Contact: mary segura ; 5635 peck rd.; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 4109127
• MDR Text Key: 4837442
• Report Number: 2020362-2014-00296
• 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: Consumer,Company Representative
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 08/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 6537QDX
• Device Catalogue Number: 6537QDX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/07/2014
• 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