ASTEAME NIPPLE GUARD

Received Aug 24, 2012 · Event occurred Sep 1, 2011

Report 2758808 · MDR key 2758808

Device

Generic name

Shield, Nipple

Manufacturer

Asteame Medical Devices Inc.

Model number

Catalog number

AMD-NPLG-00004

Lot number

Product problems

Inadequacy of Device Shape and/or Size
Fitting Problem

Patient

Dyspnea
Fungal Infection

Narrative

Description of Event or Problem

PHYSICIAN USED THE ASTEAME NIPPLE COVERS ON THE PATIENT. WHEN THE PATIENT CAME BACK FOR HER FOLLOW UP VISIT SHE HAD A FUNGAL INFECTION. PHYSICIAN FEELS THAT THEY ARE TOO TIGHT AND ARE NOT GIVING ENOUGH BREATHING ROOM.