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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 Post Operative Wound Infection (2446)
Event Date 02/13/2020
Event Type  Injury  
Manufacturer Narrative
Communication initially received stated the device was unrelated to the event. New information received from investigator on 1/28/2021 indicated possible device involvement.
 
Event Description
Two weeks post-op patient reported pain and clear fluid drainage. Pain medication and prophylactic antibiotics prescribed. Elective surgical re-exploration performed on (b)(6) 2020. Implant explanted, clear serous fluid drained, no gross evidence of infection observed. Initially reported as possible infection and unrelated to device.
 
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Brand NameECHOMARK LP
Type of DeviceIMPLANTABLE RADIOGRAPHIC MARKER
Manufacturer (Section D)
SONAVEX INC.
2835 o'donnell st
suite 200
baltimore MD 21224
Manufacturer Contact
michelle zwernemann
2835 o'donnell st
suite 200
baltimore, MD 21224
4438623223
MDR Report Key11646251
MDR Text Key246738488
Report Number3014680735-2021-00001
Device Sequence Number1
Product Code NEU
UDI-Device IdentifierB53620001
UDI-PublicB53620001
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 study
Reporter Occupation
Type of Report Initial
Report Date 02/11/2021
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 Date07/27/2020
Device Model Number2000
Device Catalogue Number2000
Device Lot NumberP-14526
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 Received01/28/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/27/2018
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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