inforMED
MalfunctionGDY

X RAY SPONGE

Received Apr 28, 2026 · Event occurred Apr 23, 2026

Report MW5187402 · MDR key 25019489

Device

Generic name

Gauze/sponge, Internal, X-ray Detectable

Catalog number

7317- 14TR

Lot number

25K047062

Patient

41 YR · Female

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

CONCERN FOR X-RAY SPONGES FALLING APART AFTER USE INSIDE PATIENT'S VAGINA. BLUE X-RAY DETECTABLE [INVALID]NOTED TO BE FALLING OUT. CHARGE NURSE, NURSE MANAGER, AND SUPPLIES MADE AWARE. SURGEON AND RESIDENT AWARE. INTRA-OPERATIVE X-RAY COMPLETED PRIOR TO PATIENT LEAVING OR. PACKAGE AND LOT NUMBER SAVED FOR INVESTIGATION WITH MANUFACTURER.