GALAFLEX 3DR

Additional Manufacturer Narrative

BASED ON THE INFORMATION PROVIDED, NO CONCLUSIONS CAN BE MADE. AS REPORTED, PATIENT EXPERIENCED POST-OP COMPLICATIONS INCLUDING WOUND DEHISCENCE AND DEBRIDEMENT. MEDICAL AFFAIRS HAS ASSESSED THE PATIENT¿S POSTOPERATIVE COURSE AS BEING SERIOUS AND LIKELY RELATED TO THE STUDY DEVICE. REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THE DEVICE WAS MANUFACTURED TO SPECIFICATION. WOUND DEHISCENCE IS A KNOWN INHERENT RISK OF THE SURGERY/USE OF THE DEVICE AND LISTED AS A POSSIBLE COMPLICATION IN THE ADVERSE REACTION SECTION OF THE INSTRUCTION FOR USE (IFU) SUPPLIED WITH THE DEVICE. THIS MDR REPORT IS RELATED TO A RETROSPECTIVE STUDY CONDUCTED TO PROACTIVELY GATHER REAL-WORLD EVIDENCE ON THE USE AND SAFETY OF THE P4HB PRODUCT FAMILY, INCLUDING GALAFLEX SCAFFOLD, GALAFLEX 3D, AND GALAFLEX 3DR. ALL SAFETY EVENTS FROM THE STUDY ARE ADJUDICATED BY THE BD MEDICAL MONITOR FOR AN INDEPENDENT ASSESSMENT OF SEVERITY AND RELATEDNESS. IN AN ABUNDANCE OF CAUTION, EVENTS FOR WHICH RELATEDNESS CANNOT BE RULED OUT ARE PROCESSED FOR MDR REPORTING. NOT RETURNED - REMAINS IMPLANTED.

Description of Event or Problem

PER CLINICAL TRIAL (B)(4): ON (B)(6) 2018, PATIENT UNDERWENT BILATERAL REVISION AUGMENTATION MASTOPEXY USING A FULL VERTICAL AND HORIZONTAL T INCISION. 2 PIECES OF GALAFORM (GALAFLEX 3DR) WERE USED. CONCOMITANT PROCEDURES INCLUDED ABDOMINOPLASTY WITH FAT GRAFTING TO BUTTOCKS. ON (B)(6) 2018, OPEN AREA, LEFT BREAST WAS REPORTED. TREATMENT WAS DEBRIDEMENT AND APPLICATION OF PRISMA DRESSING. RESOLVED WITHOUT SEQUELAE ON (B)(6) 2018. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE ADVERSE EVENT AS LIKELY RELATED TO THE DEVICE AND SERIOUS.