EXOGEN ULTRASOUND BONE HEALING SYSTEM
Received Aug 29, 2018 · Event occurred Jun 15, 2018
Report 3010203571-2018-00003 · MDR key 7829443
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
65 YR
- Lymphoma
- Lymphoma
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS EVALUATED BY THE DISTRIBUTOR AND FOUND TO HAVE 2000 MINUTES OF OPERATING TIME AND NO DEVICE ISSUES. BASED ON THE TIMELINE OF EXOGEN TREATMENT AND DIAGNOSIS OF MALIGNANT LYMPHOMA, THERE IS NO CAUSAL RELATIONSHIP BETWEEN EXOGEN TREATMENT AND THE MALIGNANT LYMPHOMA DIAGNOSIS. THE WORSENING OR "INCREASE" OF A PRE-EXISTING MALIGNANT LYMPHOMA BY LOW-INTENSITY PULSED ULTRASOUND IS HIGHLY UNLIKELY. IN GENERAL, ULTRASOUND IS NOT KNOWN TO CAUSE ANY ONTOWARD EFFECTS ON TUMOR DEVELOPMENT AND SPECIFICALLY, THERE IS NO EVIDENCE IN THE LITERATURE THAT LUPUS HAS ANY TUMOR CAUSING OR PROMOTING QUALITIES.
Description of Event or Problem
IT WAS REPORTED BY THE DISTRIBUTER ON 03 AUG 2018 THAT THE PATIENT HAD AN "INCREASE IN MALIGNANT LYMPHOMA." UPON FOLLOW UP, IT WAS REPORTED THAT THE PATIENT BEGAN EXOGEN TREATMENT ON (B)(6) 2018, WAS DIAGNOSED WITH MALIGNANT LYMPHOMA ON (B)(6) 2018, AND DISCONTINUED EXOGEN TREATMENT IN (B)(6) 2018. AS OF (B)(6) 2018, THE PATIENT WAS HOSPITALIZED FOR MALIGNANT LYMPHOMA. THE DEVICE EVALUATION BY THE DISTRIBUTOR SHOWED 2000 MINUTES OF OPERATING TIME AND NO DEVICE ISSUES.
Description of Event or Problem
ADDITIONAL INFORMATION WAS RECEIVED ON 19 SEP 2018 THAT STATED THAT THE PATIENT WAS DIAGNOSED WITH MALIGNANT LYMPHOMA ON (B)(6) 2018 WITH A LEFT FEMORAL TUMOR. THE TUMOR WAS FOUND AFTER THE FRACTURE, IT IS NOT KNOWN WHETHER THE MALIGNANT LYMPHOMA IS PRIMARY OR SECONDARY. IT WAS REPORTED THAT IT WAS A FRESH FRACTURE AND WAS NOT A PATHOLOGICAL FRACTURE. AS OF (B)(6) 2018, THE PATIENT REMAINED HOSPITALIZED FOR LEFT FEMORAL TUMOR.