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

Model Number	2000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	02/13/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.

• Brand Name: ECHOMARK LP
• Common Device Name: IMPLANTABLE RADIOGRAPHIC MARKER
• Manufacturer (Section D): SONAVEX INC.; 2835 o'donnell st; suite 200; baltimore MD 21224
• MDR Report Key: 11646251
• Report Number: 3014680735-2021-00001
• Device Sequence Number: 3100053
• Product Code: NEU
• UDI-Device Identifier: B53620001
• UDI-Public: B53620001
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K180621
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/27/2020
• Device Model Number: 2000
• Device Catalogue Number: 2000
• Device Lot Number: P-14526
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2021
• Initial Report FDA Received Date: 04/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Weight: 74