Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECKER ORTHOPEDIC APPLIANCE CO. KAFO KNEE ANKLE FOOT ORTHOSIS; ORTHOSIS, LIMB BRACE
  • 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
 

BECKER ORTHOPEDIC APPLIANCE CO. KAFO KNEE ANKLE FOOT ORTHOSIS; ORTHOSIS, LIMB BRACE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fall (1848); Limb Fracture (4518)
Event Date 07/10/2022
Event Type  Injury  
Event Description
I received a call from the patient stating that he fell and broke his right leg, above the knee, while wearing his right knee-ankle-foot orthosis (r-kafo).The patient was asked if the device could be dropped off by his wife for sequestering, which he is willing to do when it is convenient for them to do so.Patient was asked not to discard his kafo device.The patient was also informed that i will notify his clinician and her supervisor so that appropriate steps can be taken to address the issue.Patient was asked not to discard his kafo device.No manufacturer response yet.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
KAFO KNEE ANKLE FOOT ORTHOSIS
Type of Device
ORTHOSIS, LIMB BRACE
Manufacturer (Section D)
BECKER ORTHOPEDIC APPLIANCE CO.
635 executive dr
troy MI 48083
MDR Report Key16378137
MDR Text Key309579073
Report Number16378137
Device Sequence Number1
Product Code IQI
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/07/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/15/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/07/2023
Event Location Home
Date Report to Manufacturer02/15/2023
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age22630 DA
Patient SexMale
-
-