MAUDE Adverse Event Report: KNEE BRACE; JOINT, KNEE, EXTERNAL BRACE

Device Problem Device Slipped (1584)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/19/2022

Event Description

Knee brace was brought into a mri suite, the knee brace came out of hand of person holding it and attached to side of magnet.No injuries.Fda safety report id# (b)(4).

• Brand Name: KNEE BRACE
• Type of Device: JOINT, KNEE, EXTERNAL BRACE
• MDR Report Key: 13344048
• MDR Text Key: 284546215
• Report Number: MW5106950
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 01/20/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/24/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 13 YR
• Patient Sex: Female