Avalon Fetal & Maternal Patch Avalon CL Fetal & Maternal PatchRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20884838059324), received between May 19, 2023 and Apr 24, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 24, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THE PATIENT DEVELOPED A TISSUE INJURY OR SKIN TEAR FROM THE FETAL MONITORING POD, SO THE POD WAS REMOVED. NO OTHER CLINICAL INFORMATION OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19172479 ↗
• InjuryJul 10, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT A LAYER OF SKIN WAS REMOVED WHEN THE CLINICIANS REMOVED THE PATCH FROM THAT PATIENT'S ABDOMEN.

  Patient problems: Skin Tears

  MAUDE report 17286951 ↗
• InjuryMay 19, 2023Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT THE PATCHES USED WITH THE AVALON CL FETAL & MATERNAL POD CAUSED BURNING OF THE PATIENT'S SKIN.

  Patient problems: Skin Burning Sensation

  MAUDE report 16962414 ↗