MAUDE Adverse Event Report: CHUNG-A BEAUTY & HEALTH CO.,LTD. IMO SANITARY NAPKINS; PAD, MENSTRUAL, UNSCENTED

Device Problem Device Emits Odor (1425)

Patient Problems Itching Sensation (1943); Nausea (1970); Skin Inflammation/ Irritation (4545)

Event Date 02/02/2023

Event Type  Injury  

Event Description

Attention this report is to be seen by females only due to its content.I purchased a small box of sanitary napkins(menstrual pads) with the highlighted parted on it writing : large, 9p, 280mm, by the end of (b)(6) 2023 at the (b)(6) located at (b)(6), their tel#: (b)(6).It says on its box ''i'm o '' this seems to be the name of the brand.Now most of the writings on it are in korean language and this product it is made in korea and it also writes in small letters that this product is written 13% organically grown cotton in sanitary pad.I only have two or three pads that are left over and i believe they were a total of nine pads in this small box.Here are some the issues that i encountered with this product.The box was stored in a very nice corner and the temperatures were fresh at the market, before i purchased it and also i kept this box at my home in a very nice area and room temperature was fresh and cool.The package was not opened, or damaged when i purchased it.The package was in very good condition.I was happy to open it, but i got very disappointed from the bad chemical plastic odor that each of these sanitary pads had and have.I thought that i paid a lot of money for a good product, but as we know it is a nightmare to find a good product of any kind, most of them are junk.I used the sanitary napkins which caused me to have skin irritation and itchiness at the genital area and not to mention their odor caused me nausea.I stopped using them and the above mentioned symptoms went away.I thought that at the store they do not speak or understand any english, if i would call and let them know, so i decided to report this issue here, so to protect the others from buying it and damaging their own health with those napkins.Also i have noticed that usually the sellers keep selling the same stuff even when they are aware of the issues with their products, in the end of the day they need to sell and have their own money, if a customer with those issues calls the sellers they simply offer a refund and that is about it.It is written in the box at the translated part that their customer service can be reached via email:imorganic.Info@gmail.Com--- at the box is also written the m(i believe is the manufacturing date) so it is m2022 05 30 and another date that i believe it is their expiration date 2025 05 29.Please help us all to get these bad products out of our markets and let only the best be sold out there.Thank you!.

• Brand Name: IMO SANITARY NAPKINS
• Type of Device: PAD, MENSTRUAL, UNSCENTED
• Manufacturer (Section D): CHUNG-A BEAUTY & HEALTH CO.,LTD.
• MDR Report Key: 16306029
• MDR Text Key: 309264371
• Report Number: MW5114717
• 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: Other
• Type of Report: Initial

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: 02/03/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Race: White