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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SONAVEX, INC. ECHOMARK LP IMPLANTABLE RADIOGRAPHIC MARKER

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SONAVEX, INC. ECHOMARK LP IMPLANTABLE RADIOGRAPHIC MARKER Back to Search Results
Model Number 2000
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 03/12/2021
Event Type  Injury  
Manufacturer Narrative
Precautionary removal initiated by surgeon. No reports of patient pain or discomfort.
 
Event Description
Echomark was removed under local anesthesia about 4 months after initial implantation due to migration and the patient wanted it removed. No complications noted.
 
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Brand NameECHOMARK LP
Type of DeviceIMPLANTABLE RADIOGRAPHIC MARKER
Manufacturer (Section D)
SONAVEX, INC.
2835 o'donnel st
suite 200
baltimore MD 21224
Manufacturer Contact
michelle zwernemann
2835 o'donnell st
suite 200
baltimore, MD 21224
4438623223
MDR Report Key11646261
MDR Text Key244839065
Report Number3014680735-2021-00003
Device Sequence Number1
Product Code NEU
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K180621
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,study
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/16/2021
Device Model Number2000
Device Catalogue Number2000
Device Lot NumberP15069
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/12/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/16/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/09/2021 Patient Sequence Number: 1
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