MAUDE Adverse Event Report: PROCTER & GAMBLE GMBH & CO. MANUFACTURING OHE ALWAYS ULTRA/ NORMAL PADS; PAD, MENSTRUAL, UNSCENTED

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Erythema (1840); Pain (1994); Skin Inflammation/ Irritation (4545)

Event Date 02/20/2023

Event Type  Injury  

Event Description

Attention: this message is to be seen by women only due to its content, thanks.I went on (b)(6) 2023 at "universal 99 cents" store located at (b)(6).I purchased the always ultra menstrual pads, there were 16 pads in a small package which was in color green and blue from outside and its upc bar code has these numbers (b)(4) and it is written in there made in eu/ukraine/ turkey and the website given is www.Always.Eu/info and a free tel# (b)(6), seems to me that this number needs one more digit,but that is what is given in the package and maybe it is a tel# number within europe.Anyhow i tried these pads and they were scratchy and rough and irritated the skin at my inner thighs and my genital area by causing redness, and pain.They also had a greenish plastic cover in each one of them with the face of women and some big lips on them.Why is so?! anyhow i stopped using them and saved at least one and the package if you want it for further verifications.Please let me know by calling me at (b)(6) till when should i save their cover and their last piece.Thank you.

• Brand Name: ALWAYS ULTRA/ NORMAL PADS
• Type of Device: PAD, MENSTRUAL, UNSCENTED
• Manufacturer (Section D): PROCTER & GAMBLE GMBH & CO. MANUFACTURING OHE
• MDR Report Key: 16461791
• MDR Text Key: 310627140
• Report Number: MW5115331
• 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: 02/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/28/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Race: White