MAUDE Adverse Event Report: CC HSING COMPANY LIMITED DRIVE NITRO ROLLATOR

Model Number	RTL10266BK
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Muscle/Tendon Damage (4532)
Type of Reportable Event	Serious Injury
Event or Problem Description
Per mdr #2438477-2026-00017: drive devilbiss healthcare was notified of an incident involving a rollator by the end user who reported that she had difficulty pulling the seat upwards by the handle on the seat to fold the rollator.Therefore, the end user pulled up with a quick, sharp movement that resulted in a torn rotator cuff that will require physical therapy and a cortisone injection.As part of its complaint review and evaluation process, drive devilbiss healthcare will also notify the manufacturer of the product about this complaint.

• Brand Name: DRIVE NITRO ROLLATOR
• Common Device Name: ROLLATOR
• Manufacturer (Section D): CC HSING COMPANY LIMITED; no. 1, benting; bentsuo village; sikao township, jiayi county chiayi 62348 ; TW 62348
• Manufacturer (Section G): CC HSING COMPANY LIMITED; no. 1, benting; bentsuo village; sikao township, jiayi county chiayi 62348 ; TW 62348
• Manufacturer Contact: kevin walls ; 33 golden eagle lane; littleton, CO 80127 ; 7202545756
• MDR Report Key: 24859361
• Report Number: 3014273557-2026-00002
• Device Sequence Number: 13399231
• Product Code: ITJ
• UDI-Device Identifier: 00822383523927
• UDI-Public: (01)00822383523927
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/13/2026

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: RTL10266BK
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 87 YR
• Patient Sex: Unknown
• Patient Weight: 77 KG