RITMED A50044Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10686864051203), received between Mar 14, 2025 and May 9, 2025 — classified as 7 injuries.

The most frequently reported specific device problem is “Biocompatibility” (7 reports).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMay 9, 2025Biocompatibility; Biocompatibility

  A PERITONEAL DIALYSIS (PD) PATIENT CONTACTED FRESENIUS CUSTOMER SERVICE TO REPORT THAT ISLAND DRESSING MAKES HIM ITCH WHEN HE WEARS IT AND IRRITATES HIS SKIN.

  Patient problems: Itching Sensation; Skin Inflammation/ Irritation

  MAUDE report 21995870 ↗
• InjuryMay 2, 2025Biocompatibility; Biocompatibility

  PATIENT CONTACTED FRESENIUS CUSTOMER SERVICE TO REPORT THE TAPE FROM THE ISLAND DRESSING IRRITATES HER SKIN WHEN SHE USES IT. THE PATIENT INVOLVEMENT IS UNKNOWN HOWEVER THERE WAS NO HARM OR ADVERSE EVENT REPORTED.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 21953078 ↗
• InjuryMay 2, 2025Biocompatibility; Biocompatibility

  A PERITONEAL DIATYSIS (PD) PATIENT CONTACTED FRESENIUS MECICAL CARE TO REPORT THAT THE PATIENT HAD AN ALLERGIC REACTION TO THE ISLAND DRESSINGS. HE FIRST STARTED USING THEM TWO WEEKS AGO. THE SKIN AROUND HIS CATHELER WAS RED, BUMPY AND ITCHY. THEY WENT TO SEE A DERMATOLOGIST AND HE SUGGESTED THEY STOP USING THE ISLAND DRESSINGS. ONCE THEY STOPPED USING THEM HIS SKIN IMPROVED. THE PATIENT INVOLVEMENT IS UNKNOWN HOWEVER THERE WAS NO HARM OR ADVERSE EVENT REPORTED.

  Patient problems: Hypersensitivity/Allergic reaction; Skin Inflammation/ Irritation

  MAUDE report 21953019 ↗
• InjuryMay 2, 2025Biocompatibility; Biocompatibility

  A PERITONEAL DIALYSIS (PD) PATIENT CONTACTED FRESENIUS CUSTOMER SERVICE TO REPORT THAT THE 4 X 4 ISLAND DRESSING, STERILE 50/BX A50044 MAKE HIM BREAK OUT AND HE HAS A SORE, PATIENT HAS PRESENTED A BLEEDING FOR THIS MATTER. PATIENT SAID HIS NURSE HAS HIM TRYING TRANSPARENT DRESSING. LAST ORDERED ON (B)(6) 2024. THERE WAS NO PATIENT INVOLVEMENT, AND NO HARM OR ADVERSE EVENT REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Skin Inflammation/ Irritation

  MAUDE report 21952938 ↗
• InjuryApr 18, 2025Biocompatibility; Biocompatibility

  A PERITONEAL DIALYSIS (PD) PATIENT CONTACTED FRESENIUS CUSTOMER SERVICE TO REPORT THEY HAVE AN ALLERGIC REACTION WITH THE USE OF THE 4X4 ISLAND DRESSING, IT LEAVES BLISTERS, AND DISCOLORS HER SKIN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blister; Hypersensitivity/Allergic reaction; Skin Discoloration

  MAUDE report 21864187 ↗
• InjuryMar 21, 2025Biocompatibility; Biocompatibility

  A CAREGIVER OF A PERITONEAL DIALYSIS (PD) PATIENT CONTACTED CUSTOMER SERVICE TO REPORT THE PATIENT WAS ALLERGIC TO THE 4X4, ISLAND DRESSING, STERILE THAT THEY RECEIVED RECENTLY. PATIENT HAD RASH ON THE SKIN. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

  Patient problems: Hypersensitivity/Allergic reaction; Rash

  MAUDE report 21670670 ↗
• InjuryMar 14, 2025Biocompatibility; Biocompatibility

  A PERITONEAL DIALYSIS (PD) NURSE ((B)(6)) CONTACTED (B)(6) CUSTOMER SERVICE TO REPORT THAT PATIENT(B)(6)) BREAKS OUT WITH RASH WHEN USING ISLAND DRESSING. THIS REPORT REFLECTS INFORMATIONRECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

  Patient problems: Rash

  MAUDE report 21612442 ↗