MAUDE Adverse Event Report: MEDLINE INDUSTRIES; TRANSPORT WHEELCHAIR

Catalog Number MDS808200W

Device Problem Insufficient Information (3190)

Patient Problems Fall (1848); Concussion (2192)

Event Date 06/07/2015

Event Type  Injury  

Event Description

The end user fell backwards while in the chair and hit her head, suffering a concussion.

Manufacturer Narrative

It was reported that the seat ripped on both sides as the end user was sitting in the chair.She fell backwards and hit her head on asphalt, suffering a concussion.No medical intervention was provided.The sample was returned and evaluated.The transport chair was received in used condition.The seat had two cuts along the lateral stitching.The frame was slightly bent with scratches.The backrest and arm pads were in fair condition.All of the wheels showed signs of extensive use and the tires were worn.The seat was extremely worn with tears on both sides.The tears were located at the front of the seat.No manufacturing defect was identified with the sample evaluation.We cannot rule out the possibility that the end user fell onto the seat, causing it to tear.It is not clear how the tears in the front of the seat would have caused the end user to fall backwards instead of forward.We have not confirmed that the chair caused the end user to fall, but in an abundance of caution, this medwatch is being filed.

• Type of Device: TRANSPORT WHEELCHAIR
• Manufacturer (Section D): MEDLINE INDUSTRIES; one medline place; mundelein IL 60060
• Manufacturer Contact: diane christensen ; one medline place; mundelein, IL 60060 ; 8476434747
• MDR Report Key: 4878955
• MDR Text Key: 6047185
• Report Number: 1417592-2015-00056
• Device Sequence Number: 1
• Product Code: INM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: MDS808200W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2015
• Event Location: Other
• Date Manufacturer Received: 06/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 16 YR
• Patient Weight: 52