GELSYN-3 GS3111Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08033638951057), received between Oct 25, 2019 and May 20, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT WAS DIAGNOSED WITH AN INFECTION AFTER RECEIVING A GELSYN INJECTION. THE PATIENT HAD THEIR FIST INJECTION ON (B)(6) 2024. TWO DAYS POST INJECTION THE PATIENT EXPERIENCED SWELLING WITHOUT SIGNS OF INFECTION AT THE INJECTION SITE. A FOLLOW UP WITH THE PHYSICIAN WAS CONDUCTED BY THE PAITENT, THE PHYSICIAN ADVISED THE PATIENT TO APPLY COLD COMPRESS AND IF SYMPTOMS DID NOT IMPROVE, SEEK URGENT MEDICAL CARE. THREE DAYS POST INJECTION THE PATIENT WENT TO THE URGENT CARE WHERE CULTURES WERE TAKEN AND TESTED POSITIVE FOR STREP. THE PATIENT UNDERWENT THREE KNEE DRAINING PROCEDURES AND WAS TREATED WITH ANTIBIOTICS. PATIENT WAS ADMITTED TO THE HOSPITAL TO UNDERGO A WASHOUT PROCEDURE AND ADDITIONAL ANTIBIOTIC TREATMENT. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND REPORTED AS IMPROVING.

  Patient problems: Bacterial Infection; Swelling/ Edema

  MAUDE report 19353052 ↗
• InjuryJun 24, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  AS REPORTED BY THE PATIENT, 4 DAYS AFTER RECEIVING A GELSYN INJECTION THE PATIENT WAS HOSPITALIZED FOR AN INFECTION AND TREATED WITH IV ANTIBIOTICS. THE PATIENT HAD TWO PREVIOUS GELSYN INJECTIONS WITH NO ADVERSE EVENTS REPORTED. AFTER RECEIVING THE THIRD INJECTION THE PATIENT REPORTED SWELLING AND PAIN IMMEDIATELY FOLLOWING THE INJECTION. THE PATIENT INDICATED THEY WERE UNABLE TO WALK OR RAISE THEIR LEFT LEG. PATIENT HAS SEVERE OSTEOATHRITIS IN THEIR LEFT KNEE. THE PATIENT WAS RELEASED FROM THE HOSPITAL IN STABLE CONDITION AND PRESCRIBED ANTIBIOTICS FOR 6 WEEKS.

  Patient problems: Bacterial Infection; Pain; Swelling/ Edema

  MAUDE report 14800611 ↗
• InjuryNov 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS SPONTANEOUS SERIOUS REPORT RECEIVED FROM A PHYSICIAN BY BIOVENTUS (REF. (B)(4)) ON (B)(6) 2019 AND MERGED WITH THE FOLLOW-UP INFORMATION RECEIVED ON 07NOV2019 THROUGH THE SALES REP. DESCRIBES THE OCCURRENCE OF ANAPHYLACTIC SHOCK, IN A PATIENT WHO WAS PRESCRIBED GELSYN-3 (HYALURONATE SODIUM 0.84 %) INJECTION, FOR UNKNOWN INDICATION. ON (B)(6) A (B)(6) MALE PATIENT RECEIVED A GELSYN INJECTION (BATCH N. NA) IN THE RIGHT KNEE. SEVERAL DAYS LATER (ON AN UNKNOWN DATE), HE EXPERIENCED AN ANAPHYLACTIC SHOCK. THE PATIENT WAS SEEN AT THE EMERGENCY ROOM FOR EPISODE OF ANAPHYLAXIS, THAT RESOLVED IMMEDIATELY AFTER THE ER TREATMENT. NO CONCOMITANT DRUGS WERE REPORTED. PRIOR USE OF SUPARTZ (HYALURONIC ACID) LAST YEAR WITH NO ISSUES NOTED. MEDICATION CHANGE DUE TO INSURANCE. MEDICAL HISTORY: PROSTATE, HIGH BLOOD PRESSURE. THE PATIENT'S ALLERGIST STATED IT COULD HAVE/MAY HAVE BEEN RELATED TO INJECTION. IBSA COMMENT: ANAPHYLACTIC SHOCK IS A SERIOUS CONDITION. FOLLOW-UP CLARIFIED THAT THE PATIENT WENT TO THE EMERGENCY ROOM WHERE HE RECEIVED AN APPROPRIATE TREATMENT, SO THE ADVERSE EVENT HAS BEEN MEDICALLY CONFIRMED. THE CASE IS EVALUATED AS SERIOUS (MEDICALLY SIGNIFICANT), UNLISTED AND UNLIKELY

  Patient problems: Anaphylactoid / Anaphylaxis

  MAUDE report 9329277 ↗
• InjuryOct 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED HIGH BLOOD PRESSURE, DIZZINESS, CHILLS, LACK OF APPETITE, AND SWELLING AFTER RECEIVING THREE ROUNDS OF BILATERAL GELSYN-3 INJECTIONS. THE PATIENT ALSO RECEIVED ZILRETTA ON AN UNKNOWN DATE. THIS IS DOCUMENTED IN MAUDE UNDER REPORT MW5084046. THE PATIENT REPORTED HOSPITALIZATION AND DISABILITY/PERMANENT IMPAIRMENT AS EVENT OUTCOMES. IT WAS REPORTED THAT THE PATIENT IS ALSO ON RABEPRAZOLE, DOXEPIN, MECLIZINE, RANITIDINE, MOMETASONE FUROTE OINTMENT, WELCHOL, AND ZYRTEC CONCOMITANTLY.

  Patient problems: Reaction

  MAUDE report 9240859 ↗