MAUDE Adverse Event Report: J. T. POSEY CO. PASTEL BOUQUET COTTON GAIT BELT

Model Number 6531

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Customer reported the teeth do not have a secure grip on the material.Customer reported the teeth releases it's grip on the material when in use with a patient.Although the issue occurred while in use, the exact date of event is unknown.There was no patient injury reported.

Manufacturer Narrative

Product was requested to be returned for evaluation and has not been received.Note: the submission is based solely on the user facility's reported issue.Note: the quick-release buckle should be positioned to the patient's back so that the patient can not release the buckle during transfer.Release of the buckle during transfer may result in injury.Always verify the buckle is not broken or cracked and holds securely before transferring the patient.(b)(4).

• Brand Name: PASTEL BOUQUET COTTON GAIT BELT
• Manufacturer (Section D): J. T. POSEY CO.; arcadia CA
• Manufacturer Contact: sokea peou ; 5635 peck rd.; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 4523947
• MDR Text Key: 5354293
• Report Number: 2020362-2015-00029
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6531
• Device Catalogue Number: 6531
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/14/2015
• 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