MalfunctionPAJ

COLOPLAST

Received Apr 18, 2018 · Event occurred Feb 6, 2018

Report 7439415 · MDR key 7439415

Device

Generic name

Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prola

Manufacturer

Coloplast A/s

Model number

52081

Lot number

5924774

Product problems

Component Missing

Patient

64 YR

No Known Impact Or Consequence To Patient
No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

PRODUCT PIECE ON END (TIP) OF MANIPULATION WAS MISSING. WE WERE ABLE TO USE THE INSTRUMENT WITHOUT THE PIECE FOR THIS PROCEDURE. PRODUCT HAD PATIENT CONTACT BUT NO PATIENT HARM. PRODUCT WAS SAVED AND CAN BE RETURNED TO THE VENDOR.