MAUDE Adverse Event Report: UNKNOWN MENSTRUAL PADS; PAD, MENSTRUAL, UNSCENTED

Lot Number 23 037 K82 17:1

Patient Problems Unspecified Infection (1930); Itching Sensation (1943); Skin Inflammation/ Irritation (4545)

Event Date 06/19/2023

Event Type  malfunction  

Event Description

Attention due to its content this message is to be seen by women only.I purchased on (b)(6) 2023 at (b)(6) two packs with 48 pads of regular size maxi wingless.These come packed in a blue plastic bag with a photo of the pad on it and these are walgreens brand.It says on the top left corner of the package that is written:" compare to always regular size 1"***.Distributed by (b)(4) and the item # is 901 360 and there is (b)(4).Upc bar code# 049022 83746 1 ****23 037 k82 17:18 ***.I believe this number between the asterixes is the lot number.I used these in (b)(6) and they had a bad plasticy chemical odor and they caused me to have skin irritation, itchiness and infection down there at the genital area.I even have urine test that shows infection while i used these in (b)(6) 2023.Please get these pads inspected and do what is needed to be done.These have to be removed out of the market.Please and thanks and send us follow up reports in regards to our complaints.Thanks! report date august 13th of 2023.Walgreens.Reference report: #mw5144621.

• Brand Name: MENSTRUAL PADS
• Type of Device: PAD, MENSTRUAL, UNSCENTED
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17560203
• MDR Text Key: 321522399
• Report Number: MW5144620
• 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: 08/13/2023

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: 23 037 K82 17:1
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/15/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Weight: 58 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White