• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

3M COMPANY 3M FUTURO KNEE COMFORT SUPPORT WITH STABILIZER STOCKING, MEDICAL SUPPORT (TO PREVENT POOLING OF BLOOD IN LEGS) Back to Search Results
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).

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name3M FUTURO KNEE COMFORT SUPPORT WITH STABILIZER
Type of DeviceSTOCKING, MEDICAL SUPPORT (TO PREVENT POOLING OF BLOOD IN LEGS)
Manufacturer (Section D)
3M COMPANY
MDR Report Key9686612
MDR Text Key178585480
Report NumberMW5092850
Device Sequence Number1
Product Code DWL
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
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
0 PatientS WERE Involved in the Event:
Date FDA Received02/07/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL Number34-8721-5433-0/0917
Device LOT NumberN/A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

-
-