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

Model Number	STD22DDA-ELR
Medical Device Problem Code	Difficult to Fold, Unfold or Collapse (1254)
Health Effect - Clinical Code	Laceration(s) (1946)
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare received a complaint involving a wheelchair from an attendant to an end user, who reported that the end user "slid out of chair and cut her leg on either the footrest or fork assembly.The attendant also noted that "it is unclear what caused the patient to slip out of the chair." the cut was reportedly treated in the emergency room, but became infected and had to be treated further.Drive is currently investigating the incident, including attempting to retrieve the product to evaluate it.

• Brand Name: DRIVE
• Common Device Name: WHEELCHAIR
• Manufacturer (Section D): ZHENJIANG ASSURE MEDICAL EQUIPMENT CO LTD; #297 chuqiao road; zhenjiang city, jiangsu 21200 0; CH 212000
• Manufacturer (Section G): ZHENJIANG ASSURE MEDICAL EQUIPMENT CO LTD; #297 chuqiao road; zhenjiang city, jiangsu 21200 0; CH 212000
• Manufacturer Contact: jillian forster ; 99 seaview blvd. ste 210; port washington, NY 11050 ; 5169984600
• MDR Report Key: 14982330
• Report Number: 2438477-2022-00063
• Device Sequence Number: 5194843
• Product Code: IOR
• UDI-Device Identifier: 00822383191898
• UDI-Public: 00822383191898
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K112816
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 07/11/2022

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
• Device Model Number: STD22DDA-ELR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2022
• Initial Report FDA Received Date: 07/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 89 KG