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

Model Number	RTL10261BL
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Fall (1848)
Date of Event	08/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a rollator.A provider called on behalf of the patient and stated "the rollator is severed completely apart on one side of the rollator.The wheels were completely worn down.The back bar foam was torn.The patient fell and hurt her knee.Her arm hit the ground and her back was hurt." patient went to the er and got x-rays taken but no results have been shared with drive.She sustained scrapes to her legs that resulted in wound care to remove scabbing.The patient doesn't have the ability to return unit for evaluation.

• 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: 15485712
• Report Number: 2438477-2022-00099
• Device Sequence Number: 5438823
• Product Code: ITJ
• UDI-Device Identifier: 00822383262765
• UDI-Public: 00822383262765
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 09/26/2022
• Report Date (Section F): 09/26/2022

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?: Yes
• Device Model Number: RTL10261BL
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/16/2022
• Device Age: 1 YR
• Event Location: Other
• Date Report to Manufacturer: 09/30/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/26/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 81 KG
• Date Report Sent to FDA: 09/26/2022