EXOGEN ULTRASOUND BONE HEALING SYSTEM
Received Feb 9, 2021 · Event occurred Jan 9, 2021
Report 3010203571-2021-00002 · MDR key 11304790
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
69 YR
- Bacterial Infection
- Bacterial Infection
Narrative
Additional Manufacturer Narrative
H10: A REVIEW OF SUBMITTED REPORTS IDENTIFIED MISSING INFORMATION. THIS FOLLOW UP WAS COMPLETED TO ADDRESS THE MISSING INFORMATION. ADDITIONAL INFORMATION UPDATED; A2: PATIENT INFORMATION UPDATED; D4: CAT. NUMBER UPDATED, UDI: UPDATED; H4: DEVICE MANUFACTURE DATE ADDED. H11: CORRECTED: A1: PATIENT INFORMATION UPDATED; D4: MODEL NUMBER REMOVED.
Additional Manufacturer Narrative
UPDATED H6 (TYPE OF INVESTIGATION) MANUFACTURER NARRATIVE: BASED ON OUR INVESTIGATION AND THE ADDITIONAL INFORMATION RECEIVED, THIS EVENT IS UNRELATED TO THE USE OF EXOGEN.
Description of Event or Problem
FOLLOW UPS WERE COMPLETED AND ADDITIONAL INFORMATION WAS RECEIVED. IT WAS CONFIRMED THAT THE BACTERIAL INFECTION WAS NOT CAUSED BY EXOGEN USE. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AND AMPUTATION IS NO LONGER BEING CONSIDERED.
Additional Manufacturer Narrative
BASED ON THE INFORMATION AVAILABLE, NO DEFINITIVE CONCLUSIONS CAN BE MADE IN REGARDS TO THE REPORTED EVENT. ATTEMPTS FOR ADDITIONAL INFORMATION ARE IN PROGRESS. IT IS UNKNOWN IF THE PATIENT WAS TREATING ON AN OPEN WOUND. LABELING INSTRUCTS USERS THAT THE ULTRASOUND GEL IS NON-STERILE AND THAT IT SHOULD NOT BE USED ON AN OPEN WOUND.
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT WAS TREATING WITH EXOGEN FOR THREE MONTHS AND DEVELOPED A BACTERIAL INFECTION OF THE LEG THAT REQUIRED SURGERY ON (B)(6) 2021. PATIENT STATUS IS UNKNOWN, HOWEVER IT WAS REPORTED THAT AMPUTATION MAY BE NEEDED.