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	Serious Injury
Event or Problem Description
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.

• 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
• MDR Report Key: 10084351
• Report Number: 2438477-2020-00031
• Device Sequence Number: 2861730
• Product Code: IOR
• UDI-Device Identifier: 00822383133171
• UDI-Public: 822383133171
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/22/2020
• Report Date (Section F): 05/22/2020

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
• Operator of Device: Lay User/Patient
• Device Model Number: K318ADDA-SF
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/24/2020
• Device Age: 28 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/28/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 113
• Date Report Sent to FDA: 05/22/2020