MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC GAIT BELT; TRANSFER AID

Model Number DYKF1045

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 09/07/2018

Event Type  malfunction  

Event Description

The gait belt clasp came undone while staff were assisting patient to stand from chair.The clasp unbuckled, patient's knees buckled, and staff lowered patient to the floor.The rn checked another gait belt in the fall bags, and noted it too did not stay closed when staff pulled on it.Manufacturer response for gait belt, (brand not provided) (per site reporter).Medline has verified that a batch of gait belts were not made to specification.They have taken immediate action to source a domestic product and have put it into our fall bundles.

• Brand Name: GAIT BELT
• Type of Device: TRANSFER AID
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC; three lakes drive; northfield IL 60093
• MDR Report Key: 7872094
• MDR Text Key: 120121062
• Report Number: 7872094
• Device Sequence Number: 1
• Product Code: IKX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DYKF1045
• Device Catalogue Number: DYKF1045
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/10/2018
• Event Location: Hospital
• Date Report to Manufacturer: 09/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1