EXOGEN ULTRASOUND BONE HEALING SYSTEM
Received Feb 9, 2021 · Event occurred Jan 14, 2021
Report 3010203571-2021-00004 · MDR key 11305504
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
34 YR
- Unspecified Infection
- Unspecified Infection
Narrative
Additional Manufacturer Narrative
H10: A2 UPDATED PATIENT AGE, DOB; B4, G4.
Additional Manufacturer Narrative
H10: UPDATED: B4, B5, B7, G3, H2, H6: TYPE OF INVESTIGATION CODE; ADDITIONAL MANUFACTURER NARATIVE: ADDITIONAL INFORMATION RECEIVED FROM THE PHYSICIAN INDICATES PATIENT CONDITION IS UNRELATED TO USE OF THE EXOGEN GEL USE. BASED ON THE INFORMATION RECEIVED THERE WAS NO FAILURE OR MALFUNCTION OF THE EXOGEN SYSTEM. H11: CORRECTED INFORMATION: H6: HEALTH EFFECT-IMPACT CODE, INVESTIGATION FINDINGS CODE, CONCLUSION CODE.
Description of Event or Problem
ADDITIONAL INFORMATION RECEIVED. PHYSICIAN STATED PATIENT EVENT IS UNRELATED TO GEL USE. THE PHYSICIAN STATED THE PATIENT SUFFERS FROM SEVERAL CO-MORBIDITIES WHICH MAY HAVE CONTRIBUTED TO THE PATIENT'S CONDITION. THE PATIENT HAS NOT HAD ANY ADDITIONAL MEDICAL PROCEDURES AND IS CURRENTLY DOING WELL.
Additional Manufacturer Narrative
BASED ON THE INFORMATION AVAILABLE, NO DEFINITIVE CONCLUSIONS CAN BE MADE IN REGARDS TO THE REPORTED EVENT. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE. A FOLLOW UP REPORT WILL BE SUBMITTED IF NEW INFORMATION IS RECEIVED.
Description of Event or Problem
IT WAS REPORTED A PATIENT USING THE EXOGEN SYSTEM EXPERIENCED SWELLING IN THEIR THROAT AS WELL AS A RASH AROUND THEIR LEGS AND ARMS. THROUGH FOLLOW UP INVESTIGATION IT WAS LEARNED THAT THE PATIENT HAD BEEN TREATED FOR AN INFECTION. THE TYPE OF INFECTION COULD NOT BE CONFIRMED AS WELL AS THE TYPE OF TREATMENT THE PATIENT RECEIVED AS A RESULT OF THE INFECTION. THE PATIENT HAS DISCONTINUED USE OF THE GEL AND NO LONGER HAS A RASH OR INFECTION PRESENT.