MAUDE Adverse Event Report: GOODBABY ROLLATOR 9153651315; WALKER, MECHANICAL

Model Number 67100

Device Problem Break (1069)

Patient Problem Skin Tears (2516)

Event Type  Injury  

Event Description

Wife of end user reported that her husband was walking down a hallway with his 67100 rollator when the left hand brake broke off, cause the end user to fall into the wall and cut his chin.

• Brand Name: ROLLATOR 9153651315
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): GOODBABY; CH
• MDR Report Key: 4444121
• MDR Text Key: 5317965
• Report Number: 1531186-2015-00497
• 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: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 01/22/2015,01/21/2015

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: 67100
• 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: 01/22/2015
• Distributor Facility Aware Date: 01/21/2015
• Device Age: 9 MO
• Date Report to Manufacturer: 01/22/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/23/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other