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V. Mueller GL7021Recalls & reported problems

Carefusion 2200, Inc · MOGEN CIRCUMCISION CLAMP · Class 2

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885403001406), received between Jul 17, 2023 and Jul 17, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Mechanical Problem” (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

Device problems

  • Mechanical Problem1

Patient problems

  • Laceration(s)1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryJul 17, 2023Mechanical Problem; Mechanical Problem

    IT WAS REPORTED BY THE CUSTOMER THAT WHEN CLAMP WAS REMOVED, THE BABY WAS NOTED TO BE BLEEDING AND A PORTION OF THE RIGHT GLANS WAS CUT OFF IN THE CUT FORESKIN. COMPLAINT RECEIVED VIA EMAIL. CONSENT OBTAINED BY RN. RN DID CONFIRM THAT MD HAD GONE OVER THE RISKS AND BENEFITS BEFORE SHE OBTAINED THE PARENT'S SIGNATURE AND WITNESSED THE CONSENT. MD USED A MOGAN CLAMP TO PERFORM THE PROCEDURE. A TIME OUT WAS PERFORMED PRIOR TO THE PROCEDURE. MD PROCEEDED WITH THE PROCEDURE AND USED THE CLAMP. PROBE WAS USED TO LYSE ADHESIONS BETWEEN FORESKIN AND GLANS. MOGEN CLAMP WAS PLACED BEVEL DOWN. FORESKIN WAS CUT WITH SCALPEL. WHEN CLAMP WAS REMOVED, THE BABY WAS NOTED TO BE BLEEDING AND A PORTION OF THE RIGHT GLANS WAS CUT OFF IN THE CUT FORESKIN. THE PIECE OF THE GLANS WAS RETRIEVED AND PLACED IMMEDIATELY ON ICE WHILE PRESSURE WAS APPLIED BY ANOTHER MD THE ENTIRE TIME. CONTINUOUS PRESSURE APPLIED TO GLANS FOR HEMOSTASIS. THE NEONATOLOGIST WAS CALLED RIGHT AWAY AND THE BABY WAS TRANSFERRED TO THE NICU. THE NICU CALLED (B)(6) RIGHT AWAY TO TRANSFER THE BABY TO (B)(6) TO HAVE UROLOGY REATTACH CUT OFF PORTION OF THE GLANS, AND THE TEAM GAVE US AN ETA OF 20 MINUTES. MD DID INFORM THE PARENTS RIGHT

    Patient problems: Laceration(s)

    MAUDE report 17333882 ↗

Other CLAMP, CIRCUMCISION devices

All CLAMP, CIRCUMCISION devices →

Sources and updates

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