MAUDE Adverse Event Report: J. T. POSEY CO. CORAL REEF GAIT BELT LONG

Model Number 6525L

Device Problem Device Slipped (1584)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Customer reported that when the gait belts are in use in the physical therapy department, the teeth to the gait belts are not locking into the material causing the belts to slip.The date when the issue was discovered is unknown.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 reported issue statement.Results: for the evaluation a randomly selected sample was pulled from finished goods inventory (model# 6525/ lot# 4057a12).The sample was visually evaluated and revealed no product issue related to the complaint.(b)(4).

• Brand Name: CORAL REEF GAIT BELT LONG
• Manufacturer (Section D): J. T. POSEY CO.; arcadia CA
• Manufacturer (Section G): J. T. POSEY CO.; 5635 peck rd.; arcadia CA 91006
• Manufacturer Contact: mary segura ; 5635 peck rd.; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 3932855
• MDR Text Key: 4573265
• Report Number: 2020362-2014-00073
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6525L
• Device Catalogue Number: 6525L
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/05/2014
• 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