MAUDE Adverse Event Report: PROCTER & GAMBLE GMBH & CO. MANUFACTURING OHE ALWAYS MAXI; PAD, MENSTRUAL, UNSCENTED

Device Problems Device Markings/Labelling Problem (2911); Patient Device Interaction Problem (4001); Sharp Edges (4013)

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

Event Type  Injury  

Event Description

Attention due to its content, this message is to be seen by women only.On (b)(6) 2023, i went to the acme store located at (b)(6); there i purchased a package with 27(twenty seven) sanitary napkins upc bar code (b)(4).Extra heavy overnight these were very scratchy and to mention that their part on the front of them, and their part at the very end of them kept rolling from inside and pulling my skin as if i had waxed paper attached to it on both ends of these pads.I had bleeding marks in the inner part of my thighs and skin irritation due to the fact that these pads were abrasive in my skin and they caused itchiness at the areas that there were in touch with my skin too.I had to cut off their dysfunctional "flexi wings on the sides and on the back of them", so to kind of adjust them better, but it was not effective, because the fact that they were abrasive and scratchy on their surface would not change.I stopped using them and within a few days after i discontinued to use them, the skin irritation stopped.I did call acme corporate at (b)(6) and reported the issues that i mentioned above, and i did the same thing when i called always brand at (b)(6).It was hard to find their "tel#" at the package, because they need to print it in a yellow background with dark big black letters and numbers, also we need production and expiration date on their products too just like the u pantyliners does; please tell them about improving these details when they write their tel# in the package, but i managed to call them and tell them the truth.I am reporting this brand here, because even though i have called them many times in the past with issues with their products they still have the same issues persisting, so reporting them would be best.Please intervene and inspect all the other products of this brand, because they are mostly defective.And please do what is needed to be done.Please do not put a number of characters allowed here and leave it unlimited, because we might have many issues to write.Also please raise the issue here at the website when we upload images it should say:" there are two easy steps to follow to finalize the uploading of the images here: step #1-- select an image and then step#2 upload the images" and these two tabs must be in yellow background and on it must be written on dark bold capital letters, so that way is easier for us understand, because as it is right now we only select the image, but we almost never upload it.Thank you.

• Brand Name: ALWAYS MAXI
• Type of Device: PAD, MENSTRUAL, UNSCENTED
• Manufacturer (Section D): PROCTER & GAMBLE GMBH & CO. MANUFACTURING OHE
• MDR Report Key: 16529516
• MDR Text Key: 311222173
• Report Number: MW5115671
• 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: 03/09/2023

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?: No
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/10/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White