MalfunctionHGD

ESTRADIOL

Received Jun 16, 2020 · Event occurred Mar 15, 2020

Report MW5095042 · MDR key 10163118

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Product code (HGD)

Device

Generic name

Applicator, Vaginal

Manufacturer

Unk

Lot number

PHDE

Product problems

Calibration Problem

Patient

70 YR

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

Narrative

Description of Event or Problem

PATIENT CALLED TO REPORT A PRODUCT PROBLEM WITH THE TUBE APPLICATOR OF HER ESTRADIOL PRESCRIPTION. PATIENT STATED THE TUBE'S INDICATOR IS EITHER WRONG AND NOT CALIBRATED ACCURATELY, OR NOT ENOUGH.