MAUDE Adverse Event Report: JIANGYIN HUASHI MEDICAL EQUIPMENT CO.,LTD DRIVE; ROLLATOR

Model Number	RTL10266TWHL
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Laceration(s) (1946)
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare received a complaint involving a rollator from an end user's daughter, who reported that "the locking mechanism is not working which causes it to collapse resulting in falls.There was a red handle which has fallen off." the end user sustained "skin tears," one of which required "multiple visits to wound care." drive is currently investigating the incident, including attempting to retrieve the product to evaluate it.

• Brand Name: DRIVE
• Common Device Name: ROLLATOR
• Manufacturer (Section D): JIANGYIN HUASHI MEDICAL EQUIPMENT CO.,LTD; no. 589 hualu road; huashi town; jiangyin city, jiangsu 21442 1; CH 214421
• MDR Report Key: 15364484
• Report Number: 2438477-2022-00057
• Device Sequence Number: 15072507
• Product Code: ITJ
• UDI-Device Identifier: 00822383006314
• UDI-Public: 00822383006314
• 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): 09/06/2022
• Report Date (Section F): 09/06/2022

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: RTL10266TWHL
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/26/2022
• Event Location: Other
• Date Report to Manufacturer: 09/09/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/06/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 87 YR
• Patient Sex: Female
• Patient Weight: 51 KG
• Date Report Sent to FDA: 09/06/2022