MAUDE Adverse Event Report: MEDLINE INDUSTRIES BARIATRIC ROLLATOR

Model Number MDS86800XW

Device Problems Misassembled (1398); Device Misassembled During Manufacturing /Shipping (2912)

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

Event Date 08/04/2014

Event Type  malfunction  

Event Description

I purchased a bariatric rollator rolling walker with wheels from medline industries (b)(6), they sent the wrong screws that hold the wheels in the frame.I have contacted them, they want me to send pictures of screws and the hole where they screw into.I am handicapped, they are no help.

• Brand Name: BARIATRIC ROLLATOR
• Type of Device: ROLLATOR
• Manufacturer (Section D): MEDLINE INDUSTRIES
• MDR Report Key: 3999720
• MDR Text Key: 4955960
• Report Number: MW5037693
• Device Sequence Number: 1
• Product Code: ITJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MDS86800XW
• Device Lot Number: C131283461
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/05/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 75 YR
• Patient Weight: 159