MAUDE Adverse Event Report: ESTRADIOL; APPLICATOR, VAGINAL

Lot Number PHDE

Device Problem Calibration Problem (2890)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/15/2020

Event Type  malfunction  

Event Description

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.

• Brand Name: ESTRADIOL
• Type of Device: APPLICATOR, VAGINAL
• MDR Report Key: 10163118
• MDR Text Key: 195706376
• Report Number: MW5095042
• Device Sequence Number: 1
• Product Code: HGD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: PHDE
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/16/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 70 YR