EXOGEN ULTRASOUND BONE HEALING SYSTEM

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE APPLICATION SITE (LEFT KNEE) EXPERIENCED REDNESS FROM USING EXOGEN BUT NO OPEN WOUND WAS OBSERVED. PATIENT MANIPULATION OR TRAUMA ARE NOT BELIEVED TO HAVE CAUSED OR CONTRIBUTED TO THE EVENT. CULTURES WERE TAKEN DURING SURGERY WHICH WAS POSITIVE FOR STAPH AUREUS. THE TREATING PHYSICIAN STATED THAT THE ROOT CAUSE OF THE REPORTED EVENT IS RELATED TO USE OF EXOGEN AS THE PATIENT CONTINUED USING THE ULTRASOUND GEL DESPITE EXPERIENCING HYPERSENSITIVITY TO THE ULTRASOUND GEL. BASED ON THE INFORMATION AVAILABLE, THE ROOT CAUSE OF THE REPORTED EVENT IS RELATED TO USE ERROR. IT IS KNOWN AND ADDRESSED IN LABELING THAT SOME PATIENTS MAY EXPERIENCE HYPERSENSITIVITY TO THE ULTRASOUND GEL, AND IT RECOMMENDS USERS TO SWITCH TO ANOTHER COUPLING AGENT LIKE GLYCERIN IF PATIENTS EXPERIENCE HYPERSENSITIVITY TO THE ULTRASOUND GEL.

Description of Event or Problem

IT WAS REPORTED THAT THE EXOGEN PATIENT BEGAN USING HIS DEVICE ON (B)(6) 2018. EARLY IN THE TREATMENT CYCLE, THE PATIENT DEVELOPED A RASH AT THE APPLICATION SITE. THE PATIENT CONTINUED TREATMENT USING THE ULTRASOUND GEL DESPITE THE RASH AT THE APPLICATION SITE. FOLLOW-UP WITH THE PATIENT ON (B)(6) 2018 FOUND THAT THE PATIENT WAS DOING WELL WITHOUT ANY ISSUES FROM HIS TREATMENTS. ON (B)(6) 2018, THE PATIENT VISITED THE HOSPITAL AND WAS DIAGNOSED WITH A SKIN INFECTION AT THE APPLICATION SITE. ON (B)(6) 2018, THE PATIENT WAS HOSPITALIZED DUE THE SKIN INFECTION AND STOPPED USING HIS DEVICE. ON (B)(6) 2018, THE PATIENT UNDERWENT SURGERY. THE PATIENT HAS SINCE RECOVERED FROM THE INFECTION. FOLLOW-UP WITH THE TREATING PHYSICIAN REVEALED THAT THE APPLICATION SITE RASH WAS LIKELY DUE TO HYPERSENSITIVITY TO THE GEL. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE. REVIEW OF THE MANUFACTURING RECORDS FOUND THAT THE PRODUCT MET ALL SPECIFICATIONS PRIOR TO DISTRIBUTION. BASED ON THE INFORMATION AVAILABLE, THE ROOT CAUSE OF THE REPORTED APPLICATION SITE RASH IS LIKELY RELATED TO THE USE OF THE DEVICE AND USE ERROR. IT IS KNOWN AND ADDRESSED IN LABELING THAT SOME PATIENTS MAY EXPERIENCE MILD SKIN IRRITATION DUE TO HYPERSENSITIVITY TO THE GEL, AND THE OCCURRENCE OF THIS EVENT IS NOT INDICATIVE OF A PRODUCT ISSUE. PATIENTS ARE ADVISED TO SWITCH TO ANOTHER COUPLING AGENT SUCH AS MINERAL OIL OR GLYCERIN IF PATIENTS EXPERIENCE SKIN IRRITATION. BASED ON THE INFORMATION AVAILABLE, NO CONCLUSIONS CAN BE MADE IN REGARDS TO THE REPORTED SKIN INFECTION. IT IS POSSIBLE THAT THE PATIENT DEVELOPED THE SKIN INFECTION SECONDARY TO THE APPLICATION SITE RASH.

Description of Event or Problem

IT WAS REPORTED THAT THE EXOGEN PATIENT BEGAN USING HIS DEVICE ON (B)(6) 2018. EARLY IN THE TREATMENT CYCLE, THE PATIENT DEVELOPED A RASH AT THE APPLICATION SITE. THE PATIENT CONTINUED TREATMENT USING THE ULTRASOUND GEL DESPITE THE RASH AT THE APPLICATION SITE. FOLLOW-UP WITH THE PATIENT ON (B)(6) 2018 FOUND THAT THE PATIENT WAS DOING WELL WITHOUT ANY ISSUES FROM HIS TREATMENTS. ON (B)(6) 2018, THE PATIENT VISITED THE HOSPITAL AND WAS DIAGNOSED WITH A SKIN INFECTION AT THE APPLICATION SITE. ON (B)(6) 2018, THE PATIENT WAS HOSPITALIZED DUE THE SKIN INFECTION AND STOPPED USING HIS DEVICE. ON (B)(6) 2018, THE PATIENT UNDERWENT SURGERY. THE PATIENT HAS SINCE RECOVERED FROM THE INFECTION. FOLLOW-UP WITH THE TREATING PHYSICIAN REVEALED THAT THE APPLICATION SITE RASH WAS LIKELY DUE TO HYPERSENSITIVITY TO THE GEL. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE. REVIEW OF THE MANUFACTURING RECORDS FOUND THAT THE PRODUCT MET ALL SPECIFICATIONS PRIOR TO DISTRIBUTION. BASED ON THE INFORMATION AVAILABLE, THE ROOT CAUSE OF THE REPORTED APPLICATION SITE RASH IS LIKELY RELATED TO THE USE OF THE DEVICE AND USE ERROR. IT IS KNOWN AND ADDRESSED IN LABELING THAT SOME PATIENTS MAY EXPERIENCE MILD SKIN IRRITATION DUE TO HYPERSENSITIVITY TO THE GEL, AND THE OCCURRENCE OF THIS EVENT IS NOT INDICATIVE OF A PRODUCT ISSUE. PATIENTS ARE ADVISED TO SWITCH TO ANOTHER COUPLING AGENT SUCH AS MINERAL OIL OR GLYCERIN IF PATIENTS EXPERIENCE SKIN IRRITATION. BASED ON THE INFORMATION AVAILABLE, NO CONCLUSIONS CAN BE MADE IN REGARDS TO THE REPORTED SKIN INFECTION. IT IS POSSIBLE THAT THE PATIENT DEVELOPED THE SKIN INFECTION SECONDARY TO THE APPLICATION SITE RASH.