MAUDE Adverse Event Report: ULTRA THIN LINERS 100 % COTTON FROM THE " L."--BRAND; PAD, MENSTRUAL, UNSCENTED

Device Problems Device Emits Odor (1425); Device Markings/Labelling Problem (2911)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/28/2023

Event Type  Injury  

Event Description

********* attention this message is only to be seen by women due to its content!!!!!!!************************************ i purchased at (b)(6) located (b)(6) on (b)(6) 2023 the ultra-thin liners regular 100 liners and i purchased two packs of them.These have 100% pure cotton top layer with breathable back layer.These are made in mexico distributed by (b)(4) and the bar code on both packages is (b)(4) and the bar code.These have a very bad plasticky chemical odor.Yes they caused me itchiness, infection and irritation while i used them a few days ago, so that means by the end of (b)(6) 2023.Also these had some unnecessary people's faces on their packages and one of the packages did have the measurement for the liner which was 5.9 inches longer and the other one did not have why is so.Not only that we need to be given the measurement for the liners inside the packages in inches, but also in centimeters.We want these packages to be on a transparent cover so that we can see what is inside them.Please raise all these issues while dealing with report.Please inspect these liners and all the other liners and pads in our market and their intoxicating odors and compounds which they are made with and remove these from the market.Why most of the panty liners in the american markets have intoxicating odors?! ---is anyone inspecting them? -- no wonder the cancer rate is growing high in our country.Thank you! why was the person using the product? (such as what condition was it supposed to treat): menstrual cycle.Reference report: mw5120599.

Event Description

Additional information for report mw5120598 received 8/29/2023.Updated mfr information.

• Brand Name: ULTRA THIN LINERS 100 % COTTON FROM THE " L."--BRAND
• Type of Device: PAD, MENSTRUAL, UNSCENTED
• MDR Report Key: 17462515
• MDR Text Key: 320538825
• Report Number: MW5120598
• 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,Followup
• Report Date: 08/01/2023

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: 08/03/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/29/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Weight: 58 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White