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

Lot Number 22221U 110653996

Device Problem Device Emits Odor (1425)

Patient Problem Nausea (1970)

Event Date 12/15/2022

Event Type  Injury  

Event Description

Attention - due to its content this report is to be handled by females only, thanks.I purchased the saba maxi overnight menstrual pads triple protection on (b)(6) 2022 at (b)(6).There were 20 of them in a package and when i opened them a few days after i purchased those, i noticed that they had the benzene odor on them which got even worst after i used them during the menstrual cycle and they got mixed with the body fluids and that is when they released the worst odor it can be out there that made me nauseated and sick.I do not understand why it has become an issue that most of the women's menstrual pads have bad odor in the american market.Is anyone checking them out there? please make sure you double check them before they reach at the consumer's hands and do what is needed to be done; yes i reported these pads initially to the us consumer product safety commission on (b)(6) 2022, but they responded by telling me to report the issue here.Please provide us with case numbers after we report issues and do follow ups via mail, email and phone calls to let us know on the outcome of your investigations on these products.I hope you realize that a lot of us are taking the precautionary steps to prevent the mass intoxication of the population and will upscale our reports to the furthest extends in order to keep things on right path.Thank you.

• Brand Name: SABA MAXI OVERNIGHT
• Type of Device: PAD, MENSTRUAL, UNSCENTED
• Manufacturer (Section D): ESSITY HIGIENE Y SALUD MEXICO, S.A. DE C.V.
• MDR Report Key: 16067737
• MDR Text Key: 306359902
• Report Number: MW5114051
• 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: 12/24/2022

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?: Yes
• Device Lot Number: 22221U 110653996
• 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): Other
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White