EXOGEN ULTRASOUND BONE HEALING SYSTEM
Received Feb 9, 2021 · Event occurred Jan 14, 2021
Report 3010203571-2021-00003 · MDR key 11305563
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Unspecified Infection
- Unspecified Infection
Narrative
Description of Event or Problem
UPON FOLLOW UP THE PATIENT REPORTED THAT HE HAS BEEN TREATING A BROKEN HEEL BONE IN THE RIGHT FOOT FOR 8 MONTHS WITH EXOGEN, NO OPEN WOUNDS OR INFECTION ON FOOT. RECENTLY DEVELOPED ISSUES IN HIS LYMPH NODES IN NECK, UNDER ARM AND GROIN THAT REQUIRED A ROUND OF ORAL ANTIBIOTICS. PATIENT HAS CONTINUED USING EXOGEN.
Additional Manufacturer Narrative
H10: UPDATED B4, B5, B7, G3, H6 (TYPE OF INVESTIGATION) MANUFACTURER NARRATIVE: BASED ON OUR INVESTIGATION AND THE ADDITIONAL INFORMATION RECEIVED, THIS EVENT HAS BEEN ASSESSED TO BE UNRELATED TO EXOGEN USE. H11: CORRECTED H6 (HEALTH EFFECT- IMPACT CODE, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSION).
Additional Manufacturer Narrative
H10: A REVIEW OF SUBMITTED REPORTS IDENTIFIED MISSING INFORMAITON. THIS FOLLOW UP WAS COMPLETED TO ADDRESS THE MISSING INFORMATION. ADDITIONAL INFORMATION UPDATED; D4: UDI; H4: DEVICE MANUFACTURE DATE ADDED H11: CORRECTED: A1: UPDATED WITH PATIENT INFORMATION.
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
A PATIENT USING THE EXOGEN SYSTEM REPORTED HAVING MULTIPLE INFECTIONS IN THE LEGS NECK AND UNDER ARM. THE TYPE OF INFECTION IS UNKNOWN. IT IS UNKNOWN IF THE PATIENT HAD ANY INTERVENTION AND/OR TREATMENT. THE CURRENT PATIENT STATUS IS UNKNOWN.