InjuryNEU
ECHOMARK LP
Received Apr 9, 2021 · Event occurred Mar 12, 2021
Report 3014680735-2021-00003 · MDR key 11646261
Device
Generic name
Implantable Radiographic Marker
Manufacturer
Sonavex, Inc.Model number
2000Catalog number
2000
Lot number
P15069
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
52 YR
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
Narrative
Additional Manufacturer Narrative
PRECAUTIONARY REMOVAL INITIATED BY SURGEON. NO REPORTS OF PATIENT PAIN OR DISCOMFORT.
Description of Event or Problem
ECHOMARK WAS REMOVED UNDER LOCAL ANESTHESIA ABOUT 4 MONTHS AFTER INITIAL IMPLANTATION DUE TO MIGRATION AND THE PATIENT WANTED IT REMOVED. NO COMPLICATIONS NOTED.