MAUDE Adverse Event Report: UNKNOWN BLUE ADULT ROLLATOR W/BASKET 9153650332; WALKER, MECHANICAL

Model Number 65851B

Device Problem Break (1069)

Patient Problems Abrasion (1689); Fall (1848)

Event Date 02/02/2015

Event Type  Injury  

Event Description

Dealer stated that the rear frame broke at a crossbrace weld when the end user went to sit on his 65851b rollator.User fell, hurting his back and sustaining a scrape to his right knee which bled.

• Brand Name: BLUE ADULT ROLLATOR W/BASKET 9153650332
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): UNKNOWN; OH
• MDR Report Key: 4501584
• MDR Text Key: 5440728
• Report Number: 1531186-2015-00874
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Invalid Data
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 02/09/2015,02/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 65851B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/09/2015
• Distributor Facility Aware Date: 02/05/2015
• Date Report to Manufacturer: 02/09/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/10/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 35
• Patient Weight: 75