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

Model Number RTL10266

Device Problem Mechanical Problem (1384)

Patient Problems Hemorrhage/Bleeding (1888); Laceration(s) (1946); Concussion (2192)

Event Date 09/12/2023

Event Type  Injury  

Event Description

From distributor's mdr: drive devillbiss healthcare was notified of an incident involving a rollator that the curb assist broke and the end user fell, cut her head and required 12 stitches.The end user was admitted to the hospital for 2 days with a concussion and 2 pints blood loss.Devilbiss is currently investigating the incident, including attempting to retrieve the device for investigation.An update will be filed if additional information becomes available.

Manufacturer Narrative

Drive didn't send back this rollator to our factory for further investigation.The report is about the curb assist assembled on the rollator was broken and the end user fell.For each batch of curb assists we assembled on the rollator, we always pick up curb assist randomly for doing the loading tests, the loading tests are carried out regularly to inspect the quality of the curb assist.For the curb assist which was reported, according to our internal test reports, we picked up curb assist from the same batch for doing the loading test, and it passed the loading test.I have attached the pictures of the loading test.

• Brand Name: DRIVE DEVILBISS HEALTHCARE
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): CC HSING COMPANTY LIMITED; no. 1, benting; bentsuo village; sikao township, jiayi county chiayi 62348 ; TW 62348
• Manufacturer (Section G): CC HSING COMPANTY 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 ; 7209625412
• MDR Report Key: 18118845
• MDR Text Key: 327914534
• Report Number: 3014273557-2023-00001
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383288819
• UDI-Public: 822383288819
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/13/2023

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: RTL10266
• Device Catalogue Number: RTL10266
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/13/2023
• Initial Date FDA Received: 11/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Sex: Female