MAUDE Adverse Event Report: POSEY COMPANY SINGLE PATIENT USE GAIT BELT; AID, TRANSFER

Model Number 6556

Device Problem Unstable (1667)

Patient Problem Fall (1848)

Event Type  malfunction  

Manufacturer Narrative

Product was requested to be returned for evaluation and has not been received.This report is based solely on the customer's reported issue.The instructions for use state "always inspect before each use: check for broken stitches or parts; torn, cut or frayed material; or buckles that are cracked or broken and do not hold securely.Never use soiled or damaged products." manufacturer reference file # (b)(4).Product not returned.

Event Description

Customer reported while the gait belt was in use with a patient, who strongly depends on the belt, the belt began to rise.Customer believes it is possibly due to the teeth not having a strong connection into the material.Customer reported because the belt would not stabilize it began to rise causing the patient to fall.The date the incident occurred is unknown and no serious injury was reported.

Manufacturer Narrative

Lot number was added.(b)(4).

Event Description

Supplemental mdr required for product evaluation results.

• Brand Name: SINGLE PATIENT USE GAIT BELT
• Type of Device: AID, TRANSFER
• Manufacturer (Section D): POSEY COMPANY; 5635 peck road; arcadia CA 91006 0020
• Manufacturer (Section G): DONGGUAN POSEY MEDICAL DEVICE CO., LTD; fumin road, tangli village; fenggang town; dongguan / guangdong, china ; CH
• Manufacturer Contact: william hincy ; posey company; 5635 peck road; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 6126400
• MDR Text Key: 60873726
• Report Number: 2020362-2016-00048
• Device Sequence Number: 1
• Product Code: IKX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 6556
• Device Catalogue Number: 6556
• Device Lot Number: 3178D16
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1