DeRoyal 10-1281Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00749756746151), received between Jan 19, 2021 and Aug 7, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. 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.

• MalfunctionAug 7, 2024Difficult to Open or Close; Difficult to Open or Close

  THE UMBILICAL CORD CLAMPS THAT ARE IN OUR VAGINAL PACKS ARE HARD TO CLAMP AND WHEN IT CLAMPS IT COMES OFF EASILY. UNFORTUNATELY, THIS WAS NOT REPORTED ASAP UNTIL AN INCIDENT HAPPENED. IT CAME OFF FROM A NEWLY BORN BABY AND BABY LOST SOME BLOOD.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19929623 ↗
• MalfunctionJul 2, 2021Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available

  THERE WAS A NEAR MISS INVOLVING THE CLAMP FAILURE AND BABY LOST A LOT OF BLOOD WHILE BREASTFEEDING.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12106735 ↗
• InjuryJan 19, 2021Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  THE UMBILICAL CORD CLAMP DID NOT HOLD AND TENDED TO SLIP. THE PATIENT, A NEWBORN, SUFFERED SIGNIFICANT BLOOD LOSS AND RECEIVED A BLOOD TRANSFUSION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11195096 ↗