MAUDE Adverse Event Report: COM-DA HEALTHCARE CO.,LTD DRIVE; CANE

Model Number 731-852

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

Patient Problem Fall (1848)

Event Type  malfunction  

Event Description

Drive devilbiss healthcare was notified of a complaint regarding a cane by an end user, who stated that the "[cane] base is not large enough" and that she fell to the ground and sustained bruising to her hip while using it, but did not receive any medical treatment.The end user specifically stated that "there is nothing wrong with the cane except she does not feel the base is big enough." drive will continue to monitor complaints for any related trends.

• Brand Name: DRIVE
• Type of Device: CANE
• Manufacturer (Section D): COM-DA HEALTHCARE CO.,LTD; no. 1, jinzhao street, west; district, no. 6 workshop ii; zhongshan city, guangdong ; CH
• Manufacturer (Section G): COM-DA HEALTHCARE CO.,LTD; no. 1, jinzhao street, west; district, no. 6 workshop ii; zhongshan city, guangdong ; CH
• Manufacturer Contact: kevin walls ; 33 golden eagle lane; littleton, CO 80127 ; 7209625412
• MDR Report Key: 17255541
• MDR Text Key: 318470397
• Report Number: 3014644996-2023-00006
• Device Sequence Number: 1
• Product Code: IPS
• 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: Other
• Type of Report: Initial
• Report Date: 07/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 731-852
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/04/2023
• 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 Age: 75 YR
• Patient Sex: Female
• Patient Weight: 91 KG