MAUDE Adverse Event Report: ESSITY HIGIENE Y SALUD MEXICO, S.A. DE C.V. SABA ULTRA INVISIBILE ULTRA THIN OVERNIGHT; PAD, MENSTRUAL, UNSCENTED

Lot Number 2721258210056524

Device Problems Device Emits Odor (1425); Patient Device Interaction Problem (4001)

Patient Problems Nausea (1970); Vomiting (2144)

Event Date 12/18/2022

Event Type  Injury  

Event Description

Attention - this report is to be seen by females only due to its content, i purchased sabe ultra invisible ultra thin overnight menstrual pads at cvs pharmacy located at (b)(6) on (b)(6) 2022 and i tried them around (b)(6) 2022.These pads were with a benzene odor on them and when mixed with other body fluids that women discharge during the menstrual cycle they released the most intoxicating odor that could be out there, which made me nauseated and throw up.Almost like most of the other menstrual pads on the american market these pads did have a bad odor and it became worst after using them! why is so? why can we not have descend products in our market? is anyone checking these products? we need more inspectors to quality check the products before they reach our hands.We keep reporting them here.We need to have a confirmation number and a case number for every report we do.How come we never hear back from medwatch after we report issues here? please intervene, because we need to have follow ups and even phone calls from medwatch to us to tell us with the progress of these issues.Thank you very much for your attention; we will upscale the issues to the director of fda soon and to the lawmakers.

• Brand Name: SABA ULTRA INVISIBILE ULTRA THIN OVERNIGHT
• Type of Device: PAD, MENSTRUAL, UNSCENTED
• Manufacturer (Section D): ESSITY HIGIENE Y SALUD MEXICO, S.A. DE C.V.
• MDR Report Key: 16067695
• MDR Text Key: 306359156
• Report Number: MW5114050
• 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: 12/23/2022

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
• Device Lot Number: 2721258210056524
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/27/2022
• 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