MAUDE Adverse Event Report: UNKNOWN DRIVE; ROLLATOR

Model Number R800BK

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Laceration(s) (1946)

Event Date 09/13/2020

Event Type  Injury  

Event Description

According to the report received, the end user experienced "a syncopal episode due to a pre-existing cardiac condition" while using a rollator, and "slumped over." the report further states that "at that time, her leg swung around and caught a metal bar above the wheel, severely lacerating her right lower leg." the end user received treatment including debridement and a skin graft, and was left with a permanent scar.Drive is currently investigating the incident, including attempting to retrieve the product and inspect it, and will file an update as soon as additional information becomes available.

Event Description

According to the report received, the end user experienced "a syncopal episode due to a pre-existing cardiac condition" while using a rollator, and "slumped over." the report further states that "[a]t that time, her leg swung around and caught [a] metal bar above the wheel, severely lacerating her right lower leg." the end user received treatment including debridement and a skin graft, and was left with a permanent scar.Drive is currently investigating the incident, including attempting to retrieve the product and inspect it, and will file an update as soon as additional information becomes available.

• Brand Name: DRIVE
• Type of Device: ROLLATOR
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 13082957
• MDR Text Key: 283141573
• Report Number: 2438477-2021-00078
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383548579
• UDI-Public: 822383548579
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/21/2021

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: R800BK
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/21/2021
• Distributor Facility Aware Date: 12/14/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/23/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Weight: 73 KG