MAUDE Adverse Event Report: LOLA LOLA REGULAR ORGANIC COTTON TAMPONS; PAD, MENSTRUAL, UNSCENTED

Lot Number	1927487
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
I purchased lola brand regular organic cotton tampons lot #1927487 exp 2027-03-01 at walmart recently and used a single tampon for the start of my menstrual cycle today 23nov2023.The applicator itself was a bit defective since it did not keep the tampon seated which was an issue but i was ultimately able to reinsert the two pieces to become one piece upon reloading with any further problems.Unrelated to my main concern as a separate issue, but i should mention.Once initial issue was fixed, i then inserted the product into my vagina as per instruction and went about my normal daily activities.After 5 minutes i experienced a sensation of menstrual leaking which i found unusual given that it was a newly inserted tampon.Upon further assessment i found menstrual leaking around the tampon which was unsatisfactory to me so i removed the tampon by pulling the [invalid]and found it rather scratchy and irritating to my vaginal canal as it passed through.I then noticed after removal of the tampon that it was not "bloomed" (in fact, remained rather compacted- which is a different characteristic compared to other brands i have used in the past that expand and become soft in nature with initial contact of menstrual blood, which i assume is the difference as to why menstrual flow found its way around this particular lola tampon).It also had a shredded, unraveled appearance.Because of this appearance, i was highly concerned that there were fragments of the tampon cotton material left behind in my vagina so i made a manual assessment for such and found that i had remnants of cotton remaining internally, seated at various points of my vagina internally.This is highly concerning.As a consumer of this product and as medical provider, i am very concerned about not only a defective product that does not remain intact upon proper removal, but also the concerned about the risk for toxic shock syndrome if any of these remaining cotton fragments.Remain in place.These remaining cotton fragments can harbor bacteria which would be allowed to proliferate given such conditions.A menstrual hygiene product is supposed to be designed to absorb menstrual blood and be removed from the body as appropriate.This product however not only failed to complete this task, but allows for incomplete removal of the cotton tampon itself, which ultimately poses as a health risk including but not limited to vaginal irritation, vaginal excoriation, retaining of a foreign body, and toxic shock syndrome.Please look into this product and assist me in finding resolution for my health concerns and help bring awareness to the issues of this defective product amongst the menstruating community who rely on tampon products to manage menstrual hygiene.I appreciate your time.Sincerely, (b)(6).

• Brand Name: LOLA REGULAR ORGANIC COTTON TAMPONS
• Common Device Name: PAD, MENSTRUAL, UNSCENTED
• Manufacturer (Section D): LOLA; 440 park avenue south; 14th floor; new york NY 10016
• MDR Report Key: 18228366
• Report Number: MW5148527
• Device Sequence Number: 15792068
• Product Code: HHD
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 11/23/2023

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?: Yes
• Device Lot Number: 1927487
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/28/2023
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: VITAMIN D 2,000 IU DAILY BY MOUTH
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 7 MO
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Hispanic
• Patient Race: Asian, Black Or African American, White, American Indian Or Alaskan Native, Native Hawaiian Or Other Pacific Islander