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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 Insufficient Information (4580)
Event Date 01/23/2020
Event Type  Death  
Manufacturer Narrative
Communication initially received through study stated the event was unrelated to the device and unrelated to study. New information received from the investigator on 1/28/2021 indicated possible device involvement based on occurrence in 30 day post-operative window and lack of explicit exclusionary evidence. No autopsy was performed. Cause of death is unknown. No evidence of device involvement or malfunction provided.
 
Event Description
Patient death reported to have occurred in 30 day postoperative window. Cause of death unknown. No indication of implant involvement.
 
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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 Key11646254
MDR Text Key244800227
Report Number3014680735-2021-00002
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
Type of Report Initial
Report Date 02/26/2021
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 Date07/26/2020
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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