MAUDE Adverse Event Report: JAIMGSU JUMAO X-CARE MEDICAL EQUIPMENT DRIVE; MANUAL WHEELCHAIR

Model Number	K320DDA-SF
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Fall (1848)
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(4) is the initial importer of the device which is a wheelchair.The unit is being returned for evaluation which is delayed due to covid-19 related issues.End-user was given the chair after knee surgery.She used the unit for approximately 2 months.The wheel lock on the left side was loose.The unit to slide from under her and she fell.The service provider sent reps to tightened the wheel lock/brake and replaced the foot pedal because it broke.It became loose again.She reportedly fell three to four times while using the unit once landing on her backside, once on her face.She bruised her forehead and busted her lip.The first time she landed on her butt.The second time she fell she hit her head and bruised her forehead.Busted her lip.She found little black washers on the floor and a thin wire.She did not seek medical attention.

• Brand Name: DRIVE
• Common Device Name: MANUAL WHEELCHAIR
• Manufacturer (Section D): JAIMGSU JUMAO X-CARE MEDICAL EQUIPMENT; 36 danyan rd; danyang, jiangsu 21230 0; CH 212300
• MDR Report Key: 11008009
• Report Number: 2438477-2020-00062
• Device Sequence Number: 14351218
• Product Code: IOR
• UDI-Device Identifier: 00822383123370
• UDI-Public: 822383123370
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 12/14/2020
• Report Date (Section F): 12/14/2020

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: K320DDA-SF
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/13/2020
• Device Age: 3 YR
• Date Report to Manufacturer: 12/16/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 85 YR
• Patient Weight: 104
• Date Report Sent to FDA: 12/14/2020