MAUDE Adverse Event Report: UNKNOWN DRIVE; WALKER

Model Number 10210-1

Device Problem Material Twisted/Bent (2981)

Patient Problems Bruise/Contusion (1754); Fall (1848)

Event Date 08/24/2018

Event Type  Injury  

Event 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
• Type of Device: WALKER
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 10886080
• MDR Text Key: 217718616
• Report Number: 2438477-2018-00087
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383117379
• UDI-Public: 822383117379
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Lay User/Patient
• Device Model Number: 10210-1
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/23/2020
• Distributor Facility Aware Date: 08/28/2018
• Device Age: 3 YR
• Event Location: Home
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Weight: 91