MADAJET XL

Additional Manufacturer Narrative

MADA LEARNED OF A POSSIBLE SERIOUS INJURY INVOLVING A MADAJET WHEN IT WAS SERVED WITH A LAWSUIT BROUGHT BY THE PATIENT AGAINST HER TREATING PHYSICIAN AND MADA ON (B)(6) 2017. INITIAL DISCOVERY PROVIDED TO MADA IN CONNECTION WITH THE LAWSUIT INDICATED THAT THE NEEDLE FREE INJECTOR THAT WAS INVOLVED IN THE PATIENT'S INJURIES WAS A DERMOJET, WHICH IS NOT A MADA PRODUCT. HOWEVER, ON 6/26/2017, AT THE INSPECTION OF THE TREATING PHYSICIAN'S NEEDLE-FREE INJECTORS, THE TREATING PHYSICIAN PRESENTED A MADAJET RATHER THAN A DERMOJET. SINCE DISCOVERY IS CURRENTLY UNDERWAY IN THE LAWSUIT, MADA DOES NOT YET HAVE ALL AVAILABLE DATA.

Description of Event or Problem

PER PATIENT'S LAWSUIT, ON (B)(6) 2014, PATIENT UNDERWENT LOWER LID BLEPHAROPLASTY, BROW/FOREHEAD LIFT AND DERMAL GRAFTS. ON (B)(6) 2014, PATIENT PRESENTED WITH A SCAR OF THE CENTRAL UPPER PORTION OF THE LOWER RIGHT EYELID. A NEEDLE-FREE INJECTOR WAS USED TO INJECT A STEROID (KENALOG) TO TREAT THE SCAR. THEREAFTER, PATIENT COMPLAINED OF VISUAL LOSS AND BLURRINESS.