MAUDE Adverse Event Report: ZHENJIANG ASSURE MEDICAL EQUIPMENT CO LTD DRIVE; MANUAL WHEELCHAIR

Model Number	AK518ADA-AEL
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Laceration(s) (1946)
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare is the initial importer of the device which is a wheelchair.The device has not been returned for evaluation.We are filing this report in an overabundance of caution.We will file a follow-up when additional information is available.The leg rest was detached from the device at the time of the incident the front lg post came down and was open ended.It cut the user's leg.They sought medical attention at the facility where the nurse came to bandage and clean up liquid draining from the cut.The user's leg is swollen no stitches were required.A big bandage patch was applied to stop the bleeding.

• Brand Name: DRIVE
• Common Device Name: MANUAL WHEELCHAIR
• Manufacturer (Section D): ZHENJIANG ASSURE MEDICAL EQUIPMENT CO LTD; 297 chuqiaoroad; zhenjiang city, jiangsu 21200 0; CH 212000
• MDR Report Key: 12365761
• Report Number: 2438477-2021-00037
• Device Sequence Number: 11845626
• Product Code: IOR
• UDI-Device Identifier: 00822383136639
• UDI-Public: 822383136639
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/25/2021
• Report Date (Section F): 08/24/2021

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: AK518ADA-AEL
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/11/2021
• Device Age: 12 MO
• Event Location: Nursing Home
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 73
• Date Report Sent to FDA: 08/24/2021