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

Model Number	SSP118FA-SF
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870)
Date of Event	08/05/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare is the initial importer of the product which is a wheelchair.End-user disposed of the unit but provided some photos.The end-user reported that taped up the arms of the wheelchair when he noticed that the plastic on the arms split.He also noted the chair was not level.He continued to use the chair and had an incident.End-user reported that the chair spread apart and the wheels went out from under him as he tried to use the wheelchair.He fell and hit the dresser.He went to the urgent care and was diagnosed with broken ribs #4 & #5 on the left side.

• Brand Name: DRIVE
• Common Device Name: MANUAL WHEELCHAIR
• Manufacturer (Section D): ZHENJIANG ASSURE MEDICAL EQUIPMENT CO LTD; 297 chuqiao road; zhenjiang city; jiangsu,, 21200 0; CH 212000
• MDR Report Key: 7936648
• Report Number: 2438477-2018-00050
• Device Sequence Number: 940668
• Product Code: IOR
• UDI-Device Identifier: 00822383140414
• UDI-Public: 822383140414
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 10/04/2018
• Report Date (Section F): 10/04/2018

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: SSP118FA-SF
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/06/2018
• Device Age: 8 MO
• Event Location: Home
• Date Report to Manufacturer: 10/05/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 111
• Date Report Sent to FDA: 10/04/2018