MAUDE Adverse Event Report: JIANGSU JUMAO X-CARE MEDICAL DRIVE; WHEELCHAIR, MECHANICAL

Model Number K318ADDA-SF

Device Problem Mechanical Problem (1384)

Patient Problem Laceration(s) (1946)

Event Date 03/28/2022

Event Type  Injury  

Event Description

Drive devilbiss healthcare was notified of an incident involving a cruiser that the wheel did not turn well.The end user reported to have a busted lip that required 5 stitches.It is unknown what caused the incident.An update will be filed if additional information becomes available.

• Brand Name: DRIVE
• Type of Device: WHEELCHAIR, MECHANICAL
• Manufacturer (Section D): JIANGSU JUMAO X-CARE MEDICAL; no.36, danyan road; yanling town; danyang, jiangsu 21230 0; CH 212300
• MDR Report Key: 18095594
• MDR Text Key: 327670177
• Report Number: 2438477-2023-00136
• Device Sequence Number: 1
• Product Code: IOR
• UDI-Device Identifier: 00822383133171
• UDI-Public: 00822383133171
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: K318ADDA-SF
• Device Catalogue Number: K318ADDA-SF
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/28/2022
• Event Location: Home
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female