THE PHYSICIAN ADVISED THAT THERE IS NO PRODUCT ASSOCIATED WITH THE (B)(6) 2017 PROCEDURE AVAILABLE FOR EVALUATION, I.E., THE REN? VOICE WAS IMPLANTED AND FOLLOWING THE PROCEDURE, THE RENU VOICE SYRINGE AND RENU TRANSORAL NEEDLE WERE BOTH DISCARDED. CYTOPHIL INC REVIEWED THE MANUFACTURING, STERILIZATION AND POST STERILIZATION RECORDS FOR THE REN? VOICE 1.55 CC LOT V708-00040. THIS REVIEW CONFIRMED THAT ALL DEVICES RELEASED FOR DISTRIBUTION WERE MANUFACTURED IN ACCORDANCE WITH SPECIFICATIONS. A REVIEW OF CYTOPHIL, INC. COMPLAINT FILES FROM 2015-TO DATE DID NOT IDENTIFY ANY REN? VOICE COMPLAINTS OF NECROSIS. THIS REVIEW OF THREE YEAR REN? VOICE COMPLAINT DATA IDENTIFIED ONE COMPLAINT REPORT OF INFLAMMATION; A COMPLAINT REPORTED AT THE SAME TIME AS THIS COMPLAINT, BY THE SAME PHYSICIAN. CYTOPHIL, INC. HAS REQUESTED ADDITIONAL INFORMATION FROM THE FACILITY. THIS COMPLAINT INVESTIGATION IS ON-GOING. A SUPPLEMENTAL REPORT WILL BE PROVIDED.
D
Patient 1
ON (B)(6) 2017, THE PATIENT UNDERWENT AN UNEVENTFUL TRANSORAL INJECTION OF REN? VOICE FOR PRESBYLARYNGIS, BILATERAL THINNING. THE PROCEDURE WAS REPORTED TO HAVE OCCURRED IN AN OPERATING ROOM UNDER ANESTHESIA USING STANDARD EQUIPMENT, INCLUDING A STORZ TELESCOPE 5MM, ZERO DEGREE, CAMERA, AND REDO LARYNGOSCOPE. THE REN? VOICE WAS INJECTED TRANSORALLY USING A REN? TRANSORAL NEEDLE. IT WAS REPORTED THAT BOTH THE REN? VOICE AND THE REN? TRANSORAL NEEDLE DEVICE PACKAGING WERE INTACT AND UNDAMAGED WHEN OPENED BY THE PHYSICIAN. NO NOTED DIFFICULTIES WERE REPORTED TO HAVE BEEN EXPERIENCED DURING THE PROCEDURE. IT WAS NOTED THAT FOLLOWING THE PROCEDURE "THE PATIENT HAD NORMAL VOCAL CORD STRUCTURES AND APPROPRIATE BILATERAL AUGMENTATION." ON (B)(6) 2017, ONE (1) DAY POST OPERATION, IT WAS REPORTED THAT THE PATIENT CALLED THE FACILITY REPORTING SEVERE POST OPERATIVE THROAT PAIN. THE PATIENT WAS INSTRUCTED BY THE FACILITY TO COME IN FOR EVALUATION. IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT, WAS EVALUATED AND THEN DISCHARGED TO HOME, WITH A PLAN TO FOLLOW UP WITH HER PHYSICIAN IN THE CLINIC. IT WAS REPORTED THAT THE PATIENT WAS SEEN BY HER PHYSICIAN IN THE CLINIC SIX (6) DAYS LATER ON (B)(6) 2018. THE PATIENT UNDERWENT A VIDEO STROBOSCOPIC LARYNGOSCOPY WHICH WAS REPORTED TO HAVE SHOWN A "MARKED UNILATERAL SUPRAGLOTTIC ESCHAR ON THE RIGHT SUPRAGLOTTIS AND APPARENT INFLAMMATORY/NECROTIC TISSUE." THE FACILITY ALSO REPORTED THAT IT WAS "UNCLEAR IF THIS WAS AN INFECTION, INFLAMMATION, INJURY, OR REACTION TO THE IMPLANT. THE PATIENT WAS TREATED WITH CLINDAMYCIN AND DIFLUCAN TO COVER FOR POSSIBLE INFECTION." NO FURTHER TREATMENT WAS REPORTED. THE PATIENT WAS REPORTED TO HAVE RETURNED TO THE CLINIC FOR A FOLLOW UP VISIT ON (B)(6) 2018 WHEN AN ADDITIONAL STROBOSCOPY WAS PERFORMED WHICH SHOWED THAT THE ESCHAR WAS STILL PRESENT, BUT APPEARED TO BE IMPROVING. THE PATIENT'S PAIN WAS ALSO NOTED TO BE IMPROVING. THE PATIENT'S CONDITION WAS NOTED AS HAVING "IMPROVED OVER SEVERAL MONTHS." THE FACILITY CONTACTED THE PATIENT ON (B)(6) 2018 AND THE PATIENT REPORTED "HER VOICE WAS OKAY AND THAT SHE DOESN'T HAVE ANY MORE PAIN." (B)(4). (REN? TRANSORAL NEEDLE MFR. REPORT #: 3007225376-2018-00004).