DUROLANE

Additional Manufacturer Narrative

ASSESSMENT OF ADDITIONAL INFORMATION OBTAINED FROM THE REPORTER OF THE EVENT IS ONGOING.

Description of Event or Problem

IT WAS REPORTED THAT EIGHT (8) DAYS POST BILATERAL INTRA-ARTICULAR KNEE INJECTIONS ON (B)(6) 2025 A PATIENT DEVELOPED A VASCULAR OCCLUSION BLOCKING THE BLOOD FLOW AND CAUSING A PAINFUL BRUISE LIKE RASH "LIVEDOID PATTERN" PROXIMAL TO THE INTRA-ARTICULAR INJECTION SITE OF HER RIGHT KNEE. THE BILATERAL KNEE INJECTIONS WERE PRESCRIBED AND ADMINISTERED BY A PHYSICIAN BOARD-CERTIFIED IN PHYSICAL, REHABILITATION AND PAIN MEDICINE, USING FLUOROSCOPIC GUIDANCE WITH CONTRAST. THE PATIENT'S INDICATION FOR DUROLANE WAS NOT IDENTIFIED; A MEDICAL HISTORY OF RHEUMATOID ARTHRITIS WAS. THE PATIENT WAS REPORTED TO HAVE SOUGHT MEDICAL ASSISTANCE FOR THE POST-INJECTION ONSET CONDITION FROM THE PRESCRIBING PHYSICIAN. HOWEVER, THE DATE AND RESULTS OF THIS MEDICAL ASSESSMENT WERE NOT IDENTIFIED. FOLLOWING HER INITIAL ASSESSMENT THE PATIENT WAS EVALUATED BY HER PRIMARY CARE PHYSICIAN ON (B)(6) 2025. HER PRIMARY CARE PHYSICIAN DIAGNOSED 'PANNICULITIS, UNSPECIFIED' AND REFERRED HER TO A DERMATOLOGY AND COSMETIC SURGERY PRACTICE FOR EVALUATION AND TREATMENT OF HER POST-INJECTION ONSET BRUISE AND TISSUE DISCOLORATION. THE REPORTER OF THE EVENT DID NOT KNOW IF THE PRIMARY CARE PHYSICIAN WAS AWARE THE PATIENT HAD UNDERGONE BI-LATERAL INTRA-ARTICULAR INJECTION VISCOSUPPLEMENTATION PRIOR TO THE ONSET OF THE CONDITION HER EVALUATED HER FOR. DURING EVALUATION BY THE PHYSICIANS OF THE DERMATOLOGY AND COSMETIC SURGERY PRACTICE ON (B)(6) 2025 A TISSUE BIOPSY WAS PERFORMED. UPON RECEIVING AND ASSESSMENT OF THE PATIENT'S BIOPSY RESULTS ON (B)(6) 2025 THE PATIENT WAS PRESCRIBED HYALURONIDASE FOR TREATMENT OF HER RIGHT KNEE TISSUE INJURY. THE REPORTER OF THE EVENT INDICATED THE DERMATOLOGY PRACTICE WAS NOT AWARE THAT THE PATIENT HAD UNDERGONE BI-LATERAL INTRA-ARTICULAR INJECTIONS PRIOR TO THE ONSET OF THE CONDITION OF HER RIGHT KNEE. FOLLOWING ADVISEMENT OF THE DERMATOLOGY AND COSMETIC SURGERY PRACTICE THE PATIENT WAS HOSPITALIZED ON (B)(6) 2025 FOR HER HYALURONIDASE INJECTION; HOWEVER, SHE WAS TRANSFERRED DIRECTLY TO A SECOND INSTITUTION ON (B)(6) 2025 FOR THIS INJECTION AND TREATMENT OF HER CONDITION. THE REPORTER STATED THAT ON (B)(6) 2025 THE PATIENT'S CONDITION PROGRESSED TO OR BECAME MORE NECROTIC. IT WAS NOT IDENTIFIED WHO PERFORMED THIS ASSESSMENT. DURING CARE AT THE SECOND HEALTHCARE INSTITUTION THAT PATIENT RECEIVED VARIOUS ANTIBIOTICS, PAIN KILLERS, AND ANTI-INFLAMMATORIES, AS WELL AS A HYALURONIDASE INJECTION ON (B)(6) 2025. ALTHOUGH RECOMMENDED, THE PATIENT DECLINED ADDITIONAL HYALURONIDASE INJECTIONS DUE TO PAIN SHE EXPERIENCED DURING HER INITIAL INJECTION. THE PATIENT WAS DISCHARGED FROM THE SECOND HEALTHCARE INSTITUTION ON (B)(6) 2025. HER STATUS AT DISCHARGE WAS NOT SPECIFIED AND/OR REPORTED. SUBSEQUENTLY, THE PATIENT WAS ADMITTED TO A THIRD HEALTHCARE INSTITUTION THE (B)(6) 2025 DUE TO PAIN, NECROTIC TISSUE WOUND CARE, AND PASSIVE SUICIDAL IDEATIONS RELATED TO THE PAIN ASSOCIATED WITH HER LESION/NECROTIC TISSUE. THE PATIENT WAS DISCHARGED FROM THIS INSTITUTION (B)(6) 2025. HER STATUS AT DISCHARGE WAS NOT IDENTIFIED. DURING A FOLLOW-UP EVALUATION BY THE DERMATOLOGY AND COSMETIC SURGERY PRACTICE (B)(6) 2026, THE PATIENT'S WOUND WAS ASSESSED AS FULLY CLOSED, WITH A PROMINENT SCAR, BUT CONTINUING TO IMPROVE THROUGH ON-GOING CARE FROM THE DERMATOLOGY PRACTICE.