HydroMark 4010-02-15-T1Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00841911101468), received between Jul 10, 2018 and Jul 10, 2018 — classified as 1 injury.

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

• InjuryJul 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE DOCTOR, POST PROCEDURE, HYDROMARK WAS INSERTED INTO THE PATIENT WITHOUT COMPLICATIONS ON (B)(6) 2018. AFTER THE PROCEDURE THE PATIENT WAS DISCHARGED HOME ON THE SAME DAY. THE PATIENT IS KNOWN TO HAVE AN ALLERGY TO POLYETHYLENE GLYCOL (PEG). WHEN SHE GOT HOME SHE FELT TINGLING AT THE SITE OF THE HYDROMARK AND WAS AWARE SHE WAS HAVING AN ALLERGIC REACTION. SHE SELF-ADMINISTERED HER EPIPEN. THE SYMPTOMS DID NOT DIMINISH SO SHE SELF-ADMINISTERED A 2ND DOSE OF HER EPIPEN. SHE DID NOT ALERT THE HOSPITAL. SHORTLY AFTER BUT ON THE SAME DAY SHE ARRIVED AT THE HOSPITAL A AND E DEPARTMENT AND WAS TREATED AS ANAPHYLACTIC SHOCK FOR A SEVERE ALLERGIC REACTION. SHE STAYED IN ITU FOR 2 DAYS. SHE WAS THE TRANSFERRED TO THE WARD FOR 1 DAY. SHE WAS DISCHARGED ON FRIDAY (B)(6). PROCEDURE WAS COMPLETED WITH THE DEVICE. PATIENT COMPLICATION: MEDICAL/SURGICAL TREATMENT WAS REQUIRED TO RESOLVE CONSEQUENCE. ADDITIONAL DETAILS: THE SURGICAL WASH USED PRIOR TO THE PROCEDURE WAS ECOLAB HYDREX PINK WHICH ALSO CONTAINS POLYETHYLENE GLYCOL.

  Patient problems: Hypersensitivity/Allergic reaction; Patient Problem/Medical Problem; Reaction

  MAUDE report 7674287 ↗