hygh-tec V01-10024Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04260566430116), received between Jan 23, 2026 and Jan 23, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Leak/Splash” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJan 23, 2026Leak/Splash

  ON 27-OCT-2025, THE MANUFACTURER RECEIVED A VOLUNTARY FDA FORM 3500 SUBMITTED BY THE REPORTER. ACCORDING TO THE INFORMATION PROVIDED, THE PATIENT HAD A FECAL MANAGEMENT SYSTEM (FMS) IN PLACE. THE INITIAL SYSTEM WAS PLACED ON [REDACTED] AND REMOVED FOUR DAYS LATER. A NEW FMS WAS PLACED ON THE SAME DAY AND REMOVED ON [REDACTED], TWO DAYS LATER, DUE TO REPORTED BALLOON AIR LEAKAGE AND SYSTEM LEAKAGE. UPON REMOVAL, THE PATIENT WAS NOTED TO HAVE A PRESSURE INJURY ON THE RECTUM, WHICH THE REPORTER BELIEVED TO BE ASSOCIATED WITH THE HARD PLASTIC COMPONENT OF THE FMS. THE REPORTER WAS CONTACTED AND PROVIDED THE FOLLOWING DETAILS: NO MEDICAL INTERVENTION WAS NEEDED OTHER THAN WOUND CARE. SKIN AFFECTED, PT REPORTED 10/10 PAIN LEVEL. ADDITIONAL ATTEMPTS WERE MADE TO OBTAIN FURTHER DETAILS INCLUDING CLARIFICATION OF THE WOUND CARE REQUIRED; HOWEVER, THE REPORTER DECLINED TO PROVIDE ANY ADDITIONAL DETAILS.

  Patient problems: Pain; Pressure Sore/Ulcer

  MAUDE report 24161326 ↗