MAUDE Adverse Event Report: JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO.,LTD DRIVE; WHEELCHAIR

Model Number	K318ADDA-SF
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	04/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The medical device involved in the incident is a wheelchair, item # k318adda-sf.The serial number is (b)(6).The production date is 12/8/2017.1.How many similar mdrs, complaints, or service requests for the same device have you received over the past three (3) years? re: no, we never received the similar mdrs.2.If you have received reports of similar problems, please provide for each case the root cause and corrective actions taken.Not mentioned.3.Please provide any test reports and final qc inspection record conducted for this device.Attached the test reports and final qc inspection record.
Event or Problem Description
We received the email from our customer drive, the details as below: drive devilbiss healthcare is the initial importer of the device which is a wheelchair.End-user was sitting in a lift reclining chair with a wheelchair was in front of her.She put her foot forward and it hit a sharp edge of the wheel on the wheelchair.She cut two of her toes and started to bleed a lot because she is on blood thinners.The medical device involved in the incident is a wheelchair, item # k318adda-sf.The serial number is (b)(6).

• Brand Name: DRIVE
• Common Device Name: WHEELCHAIR
• Manufacturer (Section D): JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO.,LTD; no.36, danyan road; danyang, jiangsu 21230 0; CH 212300
• Manufacturer (Section G): JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO.,LTD; no.36, danyan road; danyang, jiangsu 21230 0; CH 212300
• Manufacturer Contact: belinda deng ; no.36, danyan road; danyang, jiangsu 21230-0 ; CH 212300
• MDR Report Key: 18026558
• Report Number: 3014810929-2020-00001
• Device Sequence Number: 7593545
• Product Code: IOR
• UDI-Device Identifier: 00822383133171
• UDI-Public: 822383133171
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/21/2020

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 Model Number: K318ADDA-SF
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/21/2020
• Initial Report FDA Received Date: 10/27/2023
• Was Device Evaluated by Manufacturer? (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
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 113 KG