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U.S. Department of Health and Human Services

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

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KNEE BRACE; JOINT, KNEE, EXTERNAL BRACE Back to Search Results
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).
 
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Brand Name
KNEE BRACE
Type of Device
JOINT, KNEE, EXTERNAL BRACE
MDR Report Key13344048
MDR Text Key284546215
Report NumberMW5106950
Device Sequence Number1
Product Code LNH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Received01/24/2022
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age13 YR
Patient SexFemale
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