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

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.

• Brand Name: ECHOMARK LP
• Type of Device: IMPLANTABLE 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 Key: 11646261
• MDR Text Key: 244839065
• Report Number: 3014680735-2021-00003
• Device Sequence Number: 1
• Product Code: NEU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180621
• Number of Events Reported: 1
• 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 Received: 04/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/16/2021
• Device Model Number: 2000
• Device Catalogue Number: 2000
• Device Lot Number: P15069
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 52 YR
• Patient Weight: 86