MAUDE Adverse Event Report: EQUATE PAD; PAD, MENSTRUAL, UNSCENTED

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 08/01/2019

Event Type  malfunction  

Event Description

On (b)(6) 2019 afternoon i went to change my feminine napkin or pad, (equate pad with flex wing) once i opened it i noticed a black rectangular shape in the middle of the pad, about the size of a standard business card.I was very concerned because i used pads out of this pack and finally notice this one.I contacted the company and made them aware of the issue and was told to put that one to the side and they would send me a prepaid postage envelope to send them back the product.I was also told that for my inconvenience i would be sent (b)(6) gift card.I was told this issue was due to a splicing error during processing and that i would receive a copy of the quality report, (b)(6).Is it possible to assure i get a report to make sure i was not exposed to any harmful chemicals? date the person first started taking or using the product: (b)(6) 2019; date the person stopped taking or using the product: (b)(6) 2019.Reason for use: menstrual absorption.

• Brand Name: EQUATE PAD
• Type of Device: PAD, MENSTRUAL, UNSCENTED
• MDR Report Key: 8869517
• MDR Text Key: 153829136
• Report Number: MW5088870
• Device Sequence Number: 1
• Product Code: HHD
• 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: 08/03/2019

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/06/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 30 YR