EXOGEN ULTRASOUND BONE HEALING SYSTEM
Received Feb 10, 2021 · Event occurred Jan 14, 2021
Report 3010203571-2021-00005 · MDR key 11310691
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
57 YR
- Unspecified Infection
- Unspecified Infection
Narrative
Description of Event or Problem
FOLLOW UPS WERE COMPLETED AND ADDITIONAL INFORMATION WAS RECEIVED FROM THE TREATING PHYSICIAN. THE PATIENT WAS DIAGNOSED WITH A HEMATOMA IN THAT REQUIRED ID INVOLVEMENT AND IV ANTIBIOTICS DUE TO CULTURES ON (B)(6) 2020 SHOWING ANAEROBIC GRAM POSITIVE BACILLI NON-SPORE FORMING AND ANAEROBIC GRAM POSITIVE COCCI . THE HEMATOMA WAS NOT ATTRIBUTED TO EXOGEN USE.
Additional Manufacturer Narrative
H10: UPDATED B4, B5, B6, G3, 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. H11: CORRECTED H6 (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 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. 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
THE PATIENT REPORTED USING THE EXOGEN SYSTEM BEGINNING IN (B)(6) 2020. AFTER FIVE MONTHS OF USING THE EXOGEN SYSTEM, THE PATIENT STATED HE DEVELOPED AN INFECTION AT THE APPLICATION/SURGICAL SITE. REVISION SURGERY WAS PERFORMED IN (B)(6) 2020 TO REMOVE INTERNAL FIXATION AND TREAT INFECTION AT THE SITE. PATIENT RECEIVED IV ANTIBIOTICS AND WAS HOSPITALIZED FOR ONE WEEK. CAUSE OF INFECTION IS UNKNOWN.