MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC.; WHEELCHAIR, MECHANICAL

Model Number MDS806560

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Injury (2348)

Event Date 06/13/2018

Event Type  Injury  

Event Description

Patient sat down in a wheelchair and the patient's finger was crushed between the seat and it's retaining clip.The injury included the complete avulsion of the finger tip skin and nail as well as a fracture of the distal phalanx.Manufacturer response for wheelchair, (brand not provided) (per site reporter) : the manufacturer hasn't had time to investigate.

• Type of Device: WHEELCHAIR, MECHANICAL
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 7641282
• MDR Text Key: 112465724
• Report Number: 7641282
• Device Sequence Number: 1
• Product Code: IOR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MDS806560
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/18/2018
• Device Age: 2 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 06/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention