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

Model Number 6556

Device Problem Device Slipped (1584)

Patient Problem No Patient Involvement (2645)

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 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 has not been received.

Event Description

Customer reported the teeth will not secure a tight fit on the strap.The date when the issue was discovered is unknown and there was no patient involvement.

Manufacturer Narrative

Since product was not returned the reported issue could not be confirmed.Extensive internal studies were performed and could not replicate the reported issue of the teeth not securing a tight fit.All devices tested met manufacturing specifications and performed as intended.At this time there is no evidence that a manufacturing non-conformity contributed to the reported complaint, and the instructions for use were reviewed and determined to provide adequate instructions and warnings for the safe and effective use of the device.Manufacturer reference file # (b)(4).

Event Description

Supplemental medwatch required for additional product information.

• Brand Name: SINGLE PATIENT USE GAIT BELT
• Type of Device: AID, TRANSFER
• Manufacturer Contact: william hincy ; posey company; 5635 peck road; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 6084015
• MDR Text Key: 59335583
• Report Number: 2020362-2016-00045
• 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: 11/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6556
• Device Catalogue Number: 6556
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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