PRO-DENSE™ 87SRCDK0Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889797072724), received between Feb 7, 2022 and Feb 7, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Coagulation in Device or Device Ingredient” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 7, 2022Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  PRODUCT WAS OPENED FOR CASE. PRO DENSE 15CC WAS MIXED PROPERLY FOLLOWING DIRECTIONS. WHEN SURGEON BEGAN TO IMPLANT PRODENSE MIXTURE WOULD NOT COME OUT OF SYRINGE. ALL MATERIAL IN SYRINGE HAD HARDENED BEFORE COMING OUT OF SYRINGE TO IMPLANT IN PATIENT. TOOK APART ON BACK TABLE. ALL PRODENSE WAS HARDENED AND UNABLE TO IMPLANT. WAS WITHIN WORKING TIME FOR MIXING PARAMETERS, WITH PLENTY OF TIME LEFT OVER TO IMPLANT. THE SURGEON USED PRO-STIM 15CC TO INJECT IN PATIENT. NO COMPLICATIONS. NO DELAY THAT REQUIRED ADDITIONAL ANESTHESIA, MEDICATION, SURGICAL PROCEDURE, OR THE USE OF UNINTENDED EQUIPMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13476795 ↗