inforMED
MalfunctionKOA

GOMCO STYLE CIRCUMCISION CLAMP, INFANT, 1.45CM

Received Nov 20, 2024 · Event occurred Nov 6, 2024

Report 20733354 · MDR key 20733354

Device

Generic name

Surgical Instruments, G-u, Manual (and Accessories)

Manufacturer

Elmed Incorporated

Model number

ST315503

Catalog number

ST315503

Patient

NA · Prefer Not To Disclose

  • Hemorrhage/Blood Loss/Bleeding
  • Hemorrhage/Blood Loss/Bleeding

Narrative

Description of Event or Problem

WHEN THE BELL WAS SEATED, IT WAS LOOSE. THIS CREATED AN INCOMPLETE HEMOSTASIS, RESULTING IN BLEEDING AFTER CIRCUMCISION.