Renú Gel 08-015-00-V04Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00856509002935), received between Oct 16, 2017 and Jan 8, 2019 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 8, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE PATIENT WAS REPORTED TO HAVE BEEN DIAGNOSED WITH RIGHT VOCAL FOLD PARESIS VIA A VIDEOSTROBOSCOPY PERFORMED ON (B)(6) 2018. THE ETIOLOGY OF THE PARESIS IS UNKNOWN. ON (B)(6) 2018, THE PATIENT UNDERWENT PERCUTANEOUS INJECTION WITH 0.6 CC OF RENÚ GEL THROUGH THE CRICOTHYROID. THE PHYSICIAN REPORTED THAT THE PATIENT WAS MOVING AND COUGHING DURING THE PROCEDURE. THE PHYSICIAN CONFIRMED THAT THE PATIENT WAS ABLE TO PHONATE ON (B)(6) 2018 VIA AN EXAM FOLLOWING THE INJECTION. THE PATIENT'S VOICE WAS DESCRIBED AS "HOARSE DYSPHONIA" AND THE PATIENT'S EXAM WAS NOTED TO BE "WITHIN NORMAL LIMITS." THE PATIENT WAS SEEN FOR FOLLOW-UP ON (B)(6) 2018. THE PHYSICIAN REPORTED THAT THE PATIENT PRESENTED WITH "DECREASED AMPLITUDE OF THE MUCOSAL WAVE AND ECCHYMOSIS ON THE RIGHT VOCAL FOLD." THE ECCHYMOSIS WAS REPORTED TO HAVE RESOLVED AND UNILATERAL (RIGHT SIDE ONLY) VOCAL FOLD STIFFNESS WAS NOTED DURING AN ADDITIONAL FOLLOW-UP VISIT ON (B)(6) 2018. THE VOCAL FOLD STIFFNESS WAS REPORTED TO HAVE BEEN DIAGNOSED VIA A VIDEOSTROBOSCOPY AND THROUGH LISTENING TO THE PATIENT'S VOICE. DURING THE (B)(6) 2018 FOLLOW-UP APPOINTMENT, THE PHYSICIAN NOTED THAT THERE HAD BEEN "INTERVAL DECREASE IN VOCAL FOLD SIZE

  Patient problems: Injury; No Information; Reaction, Injection Site

  MAUDE report 8229240 ↗
• InjuryMar 23, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT AN UNEVENTFUL DIAGNOSTIC LARYNGOSCOPY WITH AN ANTERIOR COMMISSURE LARYNGOSCOPE (MICROSCOPE AIDED) INJECTION OF RENÚ GEL IN THE MID AND ANTERIOR PORTIONS OF THE RIGHT VOCAL CORD, FOR LEFT TRUE CORD VOCAL PARESIS. THE PATIENT HAS A HISTORY OF TYPE 1 DIABETES, GRAVES DISEASE (WITH TACHYCARDIA) AND RESIDUAL LEFT VOCAL CORD PARESIS FOLLOWING A (B)(6) 2017 THYROIDECTOMY. IT WAS REPORTED THAT THE RENÚ GEL PRODUCT POUCH WAS IN INTACT WHEN IT WAS OPENED IN A SURGICAL CENTER OPERATING ROOM, JUST PRIOR TO THE INJECTION. APPROXIMATELY 1CC OF THE RENÚ GEL PRODUCT WAS REPORTED TO HAVE BEEN DELIVERED VIA A RENÚ TRANSORAL NEEDLE. NO NOTED DIFFICULTIES WERE REPORTED TO HAVE BEEN EXPERIENCED DURING THE PROCEDURE. WITHIN 24 HOURS OF THE (B)(6) 2018 INJECTION, THE PATIENT REPORTEDLY BEGAN EXHIBITING SYMPTOMS OF A SITE INFECTION. POST OP DAY 1 ((B)(6) 2018): "SIGNIFICANT NECK SWELLING ANTERIORLY JUST UNDER HER PREVIOUS THYROIDECTOMY INCISION" POST OP DAY 4 ((B)(6) 2018) : "INCREASE IN SWELLING, CORD SLIGHT ERYTHEMA, NO ENDOLARYNGEAL REACTION TO NOTE. TREATED WITH STEROIDS AND ANTIBIOTICS" POST OP DAY 6 ((B)(6) 2018): "UNABLE TO SWALLOW ANTIBIOT

  Patient problems: Abscess

  MAUDE report 7366257 ↗
• MalfunctionOct 16, 2017Leak/Splash; Leak/Splash

  THE ENT SURGERY CENTER REPORTED THAT WHEN THEY OPENED A RENU GEL DEVICE DURING A CASE, THE DEVICE "SEEMED TO BE BROKEN INSIDE THE ALUMINUM PACKAGE. WHEN THE NURSE OPENED IT ONTO THE FIELD, HE NOTICED THE INSIDE OF THE PACKAGE WAS WET AND DRIPPING." THE PHYSICIAN THEN ATTEMPTED TO USE THE DEVICE BUT WAS UNSUCCESSFUL IN USING THE DEVICE. IT WAS REPORTED THAT THE RENU GEL LEAKED OUT THE SIDES WHERE THE SYRINGE ATTACHED TO THE NEEDLE. THERE WAS A SECOND RENU GEL DEVICE IN THE PROCEDURE ROOM WHICH WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6952826 ↗