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

Model Number	SSP218DDA-ELR
Medical Device Problem Code	Solder Joint Fracture (2324)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	01/17/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare is the initial importer of the device which is a wheelchair.We are filing this report in an over-abundance of caution due to an mdr regression analysis.The product was not returned for evaluation by the end user.Device was in use when the weld broke.The user was injured on her lower left extremity.Additional details are not available.Historical data for these complaints of the same nature was reviewed and found very limited reporting which shows no trend.

• Brand Name: DRIVE
• Common Device Name: WHEELCHAIR, MANUAL
• Manufacturer (Section D): JIANGSU JUMAO X-CARE MEDICAL; 36 danyan rd; danyang, jiangsu 21230 0; CH 212300
• MDR Report Key: 10936654
• Report Number: 2438477-2018-00089
• Device Sequence Number: 16304121
• Product Code: IOR
• UDI-Device Identifier: 00822383140452
• UDI-Public: 822383140452
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 12/02/2020
• Report Date (Section F): 12/02/2020

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: SSP218DDA-ELR
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/17/2018
• Device Age: 2 MO
• Date Report to Manufacturer: 12/03/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/02/2020
• 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: Hospitalization
• Date Report Sent to FDA: 12/02/2020