MAUDE Adverse Event Report: COMBO MEDICAL EQUIPMENT DRIVE; ROLLATOR

Model Number	10257BL-1
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Fall (1848); Head Injury (1879)
Date of Event	05/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a rollator by an end user, who reported that the left leg caster "collapsed while the brakes were engaged, and the device was stationery," causing him to fall backwards onto a concrete path, hitting his head, scratching the back of his left leg, and aggravating an existing back injury.The end user reported that the "hardware came loose and caused for to detach from stem." the end user declined to return the unit for evaluation.

• Brand Name: DRIVE
• Common Device Name: ROLLATOR
• Manufacturer (Section D): COMBO MEDICAL EQUIPMENT; .6 tongxing east rd; dongsheng town; zhongshan city, guangdong 52841 4; CH 528414
• MDR Report Key: 14978294
• Report Number: 2438477-2022-00048
• Device Sequence Number: 5727789
• Product Code: ITJ
• UDI-Device Identifier: 00822383290331
• UDI-Public: 822383290331
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/11/2022
• Report Date (Section F): 07/11/2022

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 10257BL-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/09/2022
• Device Age: 10 MO
• Event Location: Other
• Date Report to Manufacturer: 06/15/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/11/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 123 KG
• Date Report Sent to FDA: 07/11/2022