EXOGEN ULTRASOUND BONE HEALING SYSTEM
Received Jul 17, 2019 · Event occurred Apr 25, 2019
Report 3010203571-2019-00004 · MDR key 8800373
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Wound Infection
- Wound Infection
Narrative
Additional Manufacturer Narrative
BASED ON THE AVAILABLE INFORMATION, WE WOULD SURMISE THAT THE PATIENT REACTED TO THE GEL WHICH EXPLAINS THE SKIN CHANGES (REDNESS, BLISTERS, SKIN ULCERATION). HE ALSO SEEMS TO HAVE DEVELOPED A BONE INFECTION MOST LIKELY UNRELATED TO THE EXOGEN TREATMENT AT THE FRACTURE SITE (OSTEOMYELITIS) WHICH CAUSED DISCHARGE VIA THE POINT OF LEAST RESISTANCE (TREATMENT SITE). IT IS KNOWN AND ADDRESSED IN LABELING THAT SOME PATIENTS MAY EXPERIENCE HYPERSENSITIVITY TO THE ULTRASOUND COUPLING GEL, AND PATIENTS ARE ADVISED THAT THE EXOGEN ULTRASOUND SIGNAL WILL ALSO COUPLE TO THE SKIN USING MINERAL OIL.
Description of Event or Problem
AS REPORTED BY THE HEALTHCARE PROFESSIONAL ON 18 JUN 2019, THE EXOGEN PATIENT WAS ADVISED BY HIS ORTHOPAEDIC CONSULTANT SURGEON TO STOP THE USE OF THE EXOGEN DEVICE. THE PATIENT HAD AN ADVERSE REACTION WHICH RESULTED IN THE SKIN BECOMING VERY IRRITATED AND BROKEN DOWN LOCALLY TO WHERE THE DEVICE WAS APPLIED. THE PATIENT DEVELOPED A SUSPECTED INFECTION WITHIN HIS TIBIA BONE AND THE EXUDATE WAS CONTINUOUSLY OOZING THROUGH THE AREA OF BROKEN DOWN SKIN. THE PATIENT HAS BEEN ALMOST 100% COMPLIANT SINCE HE STARTED THE TREATMENT IN (B)(6) 2018. HIS PHYSICIAN HAS BEEN COMPLETING REGULAR X-RAYS TO MONITOR ANY SIGNS OF PROGRESS WITH THE TIBIAL HEALING AND ADVISED THAT THERE HAS BEEN NO PROGRESS SINCE THE COMMENCEMENT OF THE EXOGEN. THE ATTENDING PHYSICIAN'S CAUSALITY WAS "NOT RELATED," AND HE BELIEVED THE SYMPTOMS WERE RELATED TO UNKNOWN COMORBIDITIES.
Additional Manufacturer Narrative
BASED ON THE AVAILABLE INFORMATION, WE WOULD SURMISE THAT THE PATIENT REACTED TO THE GEL WHICH EXPLAINS THE SKIN CHANGES (REDNESS, BLISTERS, SKIN ULCERATION). HE ALSO SEEMS TO HAVE DEVELOPED A BONE INFECTION MOST LIKELY UNRELATED TO THE EXOGEN TREATMENT AT THE FRACTURE SITE (OSTEOMYELITIS) WHICH CAUSED DISCHARGE VIA THE POINT OF LEAST RESISTANCE (TREATMENT SITE). IT IS KNOWN AND ADDRESSED IN LABELING THAT SOME PATIENTS MAY EXPERIENCE HYPERSENSITIVITY TO THE ULTRASOUND COUPLING GEL, AND PATIENTS ARE ADVISED THAT THE EXOGEN ULTRASOUND SIGNAL WILL ALSO COUPLE TO THE SKIN USING MINERAL OIL.
Description of Event or Problem
AS REPORTED BY THE HEALTHCARE PROFESSIONAL ON 18 JUN 2019, THE EXOGEN PATIENT WAS ADVISED BY HIS ORTHOPAEDIC CONSULTANT SURGEON TO STOP THE USE OF THE EXOGEN DEVICE. THE PATIENT HAD AN ADVERSE REACTION WHICH RESULTED IN THE SKIN BECOMING VERY IRRITATED AND BROKEN DOWN LOCALLY TO WHERE THE DEVICE WAS APPLIED. THE PATIENT DEVELOPED A SUSPECTED INFECTION WITHIN HIS TIBIA BONE AND THE EXUDATE WAS CONTINUOUSLY OOZING THROUGH THE AREA OF BROKEN DOWN SKIN. THE PATIENT HAS BEEN ALMOST 100% COMPLIANT SINCE HE STARTED THE TREATMENT IN (B)(6) 2018. HIS PHYSICIAN HAS BEEN COMPLETING REGULAR X-RAYS TO MONITOR ANY SIGNS OF PROGRESS WITH THE TIBIAL HEALING AND ADVISED THAT THERE HAS BEEN NO PROGRESS SINCE THE COMMENCEMENT OF THE EXOGEN.