MAUDE Adverse Event Report: CC HSING COMPANY LIMITED DRIVE DEVILBISS; WALKER, MECHANICAL

Model Number 10266HD-BK

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

Patient Problem Laceration(s) (1946)

Event Date 09/20/2023

Event Type  Injury  

Event Description

Drive devilbiss healthcare received a complaint regarding a rollator from an end user, who reported that she fainted.When she fell, she reportedly cut herself on the rollator's "back brake." she did not identify any specific defect or malfunction in the rollator.The end user, who is diabetic, reported receiving 19 stitches and developing a blood infection, for which she was hospitalized.Drive is currently attempting to investigate the incident, including inspecting the product through the end user's attorney.Drive will file an update as soon as additional information becomes available.

• Brand Name: DRIVE DEVILBISS
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): CC HSING COMPANY LIMITED; no. 1 benting; bentsuo village, sikao chiayi 26989 61; TW 2698961
• MDR Report Key: 18537919
• MDR Text Key: 333168159
• Report Number: 2438477-2024-00004
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383931654
• UDI-Public: 822383931654
• 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
• Report Date: 01/18/2024

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: 10266HD-BK
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/18/2024
• Distributor Facility Aware Date: 11/03/2023
• Event Location: Home
• Date Report to Manufacturer: 01/18/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/18/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Sex: Female