ECHOMARK LP
Received Apr 9, 2021 · Event occurred Feb 13, 2020
Report 3014680735-2021-00001 · MDR key 11646251
Device
Generic name
Implantable Radiographic Marker
Manufacturer
Sonavex Inc.Model number
2000Catalog number
2000
Lot number
P-14526
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
58 YR
- Post Operative Wound Infection
- Post Operative Wound Infection
Narrative
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.
Description of Event or Problem
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.