MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; WHEELCHAIR,EXCEL,22" WIDE,RDLA,S/A FT

Catalog Number MDS806800

Device Problem Material Integrity Problem (2978)

Patient Problem Swelling/ Edema (4577)

Event Date 07/10/2023

Event Type  Injury  

Event Description

According to the customer, on (b)(6) 2023 the customer was sitting in the wheel chair when she turned and the brake "popped off" causing the wheel chair to "run over" her right foot.

Manufacturer Narrative

According to the customer, on (b)(6) 2023 the customer was sitting in the wheel chair when she turned and the brake "popped off" causing the wheel chair to "run over" her right foot.The customer reported she had swelling in her foot and it "instigated" her arthritis.The customer reported she went to her physician, received a "cortisone shot" in her foot, and is now "feeling better".The customer reported she is continuing to use the broken wheelchair.This writer advised the customer to stop using the broken device.Sample requested for return evaluation.No additional information is available at this time.It has been determined that the reported event caused or contributed to serious injury, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Type of Device: WHEELCHAIR,EXCEL,22" WIDE,RDLA,S/A FT
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 17487724
• MDR Text Key: 320679394
• Report Number: 1417592-2023-00331
• Device Sequence Number: 1
• Product Code: IOR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: MDS806800
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other