MAUDE Adverse Event Report: MARKET DRIVE BRANDS, LLC. SURE AND FRESH MAXI PADS SUPER HEAVY FLOW; PAD, MENSTRUAL, UNSCENTED

Lot Number 02033132

Patient Problems Itching Sensation (1943); Skin Inflammation/ Irritation (4545)

Event Date 11/30/2023

Event Type  Injury  

Event Description

Attention !!! due to its content this message is for a female that is why i need a female to see and deal with this complaint.Thank you! i ordered these panty liners from the cvs online their upc bar code # 8 500 22 917 47 made in mexico tel # 1--855--648--2660 their email address is info@marketdrivebrands.Com these are manufactured for market drive brands llc.5900 balcones dr.Ste 100 austin texas.When they arrived they had a bad chemical odor and caused me to have itchiness and irritations.I am reporting them here today with the hopes that these items will be improved.Also we want the manufacturer to make them longer and with a thick layer of organic cotton gauze on their top too as well.Please intervene ,because 99% of the menstrual pads sold in the usa market are having bad odors and even worst some of them are scratchy and need 100% organic cotton gauze that is sterilized in their top part too for a comfortable feel and better absorption.It is antihuman to have these pads with chemical odors and to have them scratch us and feel like having a nonabsorbable plastic liner that is rough against our delicate skin and mucosae down at the genital area like a nail smoother.Thank you for your attention towards these matters!.

• Brand Name: SURE AND FRESH MAXI PADS SUPER HEAVY FLOW
• Type of Device: PAD, MENSTRUAL, UNSCENTED
• Manufacturer (Section D): MARKET DRIVE BRANDS, LLC.; 5900 balcones drive; ste 100; austin TX 78737
• MDR Report Key: 18446324
• MDR Text Key: 332252729
• Report Number: MW5149772
• 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: 12/31/2023

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 Lot Number: 02033132
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/03/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White