MAUDE Adverse Event Report: UNKNOWN DRIVE; WALKER

Model Number	10210-1
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Fall (1848)
Date of Event	08/24/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare is the initial importer of the device which is a walker.We are filing this report in an over-abundance of caution due to an mdr regression analysis.The unit was disposed of prior to evaluation.The back leg bent while in use.The end-user fell and hit her knee and head.She went tot he doctor the next day.No serious injury was sustained.Historical data of complaints of this nature was reviewed and found very limited with no trend and a (b)(4) percent defect rate over the prior two years.Root cause cannot be determined as the unit was discarded.

• Brand Name: DRIVE
• Common Device Name: WALKER
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 10886080
• Report Number: 2438477-2018-00087
• Device Sequence Number: 16917801
• Product Code: ITJ
• UDI-Device Identifier: 00822383117379
• UDI-Public: 822383117379
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 11/23/2020
• Report Date (Section F): 11/23/2020

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: 10210-1
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/28/2018
• Device Age: 3 YR
• Event Location: Home
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 91
• Date Report Sent to FDA: 11/23/2020