MAUDE Adverse Event Report: 3M COMPANY 3M FUTURO KNEE COMFORT SUPPORT WITH STABILIZER; STOCKING, MEDICAL SUPPORT (TO PREVENT POOLING OF BLOOD IN LEGS)

Model Number 34-8721-5433-0/0917

Device Problem Break (1069)

Patient Problem Pain (1994)

Event Date 02/04/2020

Event Type  Injury  

Event Description

I purchased a 3m futuro support brace on (b)(6) 2019.I used it to support an arthritic left knee when i exercise at my fitness center.During exercise on (b)(6) 2020, i noticed a sharp pain on the left side of my knee cap.When i removed the support brace, i noticed that the steel stabilizer mesh broke in half and pierced through the fabric digging into my knee.Later yesterday, i returned the support brace to (b)(6) and received a new one.The support brace does work well but the manufacturer should be made aware of the defect with the stabilizer and it¿s ability to do bodily harm.Fda safety report id # (b)(4).

• Brand Name: 3M FUTURO KNEE COMFORT SUPPORT WITH STABILIZER
• Type of Device: STOCKING, MEDICAL SUPPORT (TO PREVENT POOLING OF BLOOD IN LEGS)
• Manufacturer (Section D): 3M COMPANY
• MDR Report Key: 9686612
• MDR Text Key: 178585480
• Report Number: MW5092850
• Device Sequence Number: 1
• Product Code: DWL
• UDI-Device Identifier: 05113120075
• UDI-Public: 05113120075
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/05/2020

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
• Device Operator: Lay User/Patient
• Device Model Number: 34-8721-5433-0/0917
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/07/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 97