DeRoyal 13662067Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00749756283281), received between Oct 9, 2023 and Dec 12, 2023 — classified as 13 injuries, 1 malfunction.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (14 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryDec 12, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  SEVERAL FEMALE PATIENTS BROKE OUT IN A RASH ACROSS THE AREA WHERE THE BINDER WAS ON THEIR SKIN. USED IN LABOR AND DELIVERY POST C SECTION.

  Patient problems: Rash

  MAUDE report 18310577 ↗
• InjuryDec 12, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  SEVERAL FEMALE PATIENTS BROKE OUT IN A RASH ACROSS THE AREA WHERE THE BINDER WAS ON THEIR SKIN. USED IN LABOR AND DELIVERY POST C SECTION.

  Patient problems: Rash

  MAUDE report 18310576 ↗
• InjuryDec 12, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  SEVERAL FEMALE PATIENTS BROKE OUT IN A RASH ACROSS THE AREA WHERE THE BINDER WAS ON THEIR SKIN. USED IN LABOR AND DELIVERY POST C SECTION.

  Patient problems: Rash

  MAUDE report 18310575 ↗
• InjuryDec 12, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  SEVERAL FEMALE PATIENTS BROKE OUT IN A RASH ACROSS THE AREA WHERE THE BINDER WAS ON THEIR SKIN. USED IN LABOR AND DELIVERY POST C SECTION.

  Patient problems: Rash

  MAUDE report 18310563 ↗
• InjuryDec 12, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  SEVERAL FEMALE PATIENTS BROKE OUT IN A RASH ACROSS THE AREA WHERE THE BINDER WAS ON THEIR SKIN. USED IN LABOR AND DELIVERY POST C SECTION.

  Patient problems: Rash

  MAUDE report 18310552 ↗
• InjuryDec 12, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  SEVERAL FEMALE PATIENTS BROKE OUT IN A RASH ACROSS THE AREA WHERE THE BINDER WAS ON THEIR SKIN. USED IN LABOR AND DELIVERY POST C SECTION.

  Patient problems: Rash

  MAUDE report 18310549 ↗
• InjuryDec 12, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  SEVERAL FEMALE PATIENTS BROKE OUT IN A RASH ACROSS THE AREA WHERE THE BINDER WAS ON THEIR SKIN. USED IN LABOR AND DELIVERY POST C SECTION.

  Patient problems: Rash

  MAUDE report 18310543 ↗
• InjuryDec 12, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  SEVERAL FEMALE PATIENTS BROKE OUT IN A RASH ACROSS THE AREA WHERE THE BINDER WAS ON THEIR SKIN. USED IN LABOR AND DELIVERY POST C SECTION.

  Patient problems: Rash

  MAUDE report 18310541 ↗
• InjuryDec 12, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  SEVERAL FEMALE PATIENTS BROKE OUT IN A RASH ACROSS THE AREA WHERE THE BINDER WAS ON THEIR SKIN. USED IN LABOR AND DELIVERY POST C SECTION.

  Patient problems: Rash

  MAUDE report 18310528 ↗
• InjuryDec 12, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  SEVERAL FEMALE PATIENTS BROKE OUT IN A RASH ACROSS THE AREA WHERE THE BINDER WAS ON THEIR SKIN. USED IN LABOR AND DELIVERY POST C SECTION.

  Patient problems: Rash

  MAUDE report 18310526 ↗
• InjuryDec 12, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  SEVERAL FEMALE PATIENTS BROKE OUT IN A RASH ACROSS THE AREA WHERE THE BINDER WAS ON THEIR SKIN. USED IN LABOR AND DELIVERY POST C SECTION.

  Patient problems: Rash

  MAUDE report 18310525 ↗
• InjuryDec 12, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  SEVERAL FEMALE PATIENTS BROKE OUT IN A RASH ACROSS THE AREA WHERE THE BINDER WAS ON THEIR SKIN. USED IN LABOR AND DELIVERY POST C SECTION.

  Patient problems: Rash

  MAUDE report 18310513 ↗
• InjuryOct 9, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  RASH REQUIRED MEDICAL ATTENTION TO PREVENT IMPAIRMENT: PHYSICAL ASSESSMENT AND TREATMENT WITH ORAL STEROIDS AND ANTIBIOTICS.

  Patient problems: Rash

  MAUDE report 17896455 ↗
• MalfunctionOct 9, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  PATIENT COMPLAINED OF A RASH LOCATED WHERE THE ABDOMINAL BINDER WAS LOCATED. FOR THIS PATIENT, USE OF THE ABDOMINAL BINDER WAS IMMEDIATELY DISCONTINUED, RESULTING IN THE RASH RESOLVING SHORTLY.

  Patient problems: Rash

  MAUDE report 17896450 ↗