MAUDE Adverse Event Report: Procter & Gamble co. Tampax Pearl Tampons ¿ Light/Regular/Super Triple-Pack, 47 Count; Tampon, Menstrual, Unscented

Lot Number	5296243010 10
Medical Device Problem Codes	Product Quality Problem (1506); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
I'm reporting a recurring product-quality issue with tampax pearl tampons.I have used the same product from tampax for years.Over at least three recent boxes, i've repeatedly encountered malformed applicator tips but initially assumed it was single incidents.However in the most recent box, i opened three tampons in a row and all three were visibly defective: two had applicator petals already spread open with the cotton exposed, and one had a petal folded inward, attempting to insert the open applicators was really painful.I am attaching photos of the defective applicators and the package.Product: tampax pearl light/regular/super triple-pack, 47 count.Reference reports mw6002397 mw6002398.Annex a: 1506, 2978.Annex e: 4582.Annex f: 2199.Annex g: 3030.This report reflects tampon #1.

• Brand Name: Tampax Pearl Tampons ¿ Light/Regular/Super Triple-Pack, 47 Count
• Common Device Name: Tampon, Menstrual, Unscented
• Manufacturer (Section D): Procter & Gamble co.
• MDR Report Key: 50789477
• Report Number: MW6002396
• Device Sequence Number: 21475618
• Product Code: HEB
• UDI-Device Identifier: 00073010714472
• UDI-Public: 00073010714472
• Combination Product (Y/N): N
• 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): 09/12/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 5296243010 10
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/16/2026
• Patient Sequence Number: 1
• Patient Age: 26 YR
• Patient Sex: Female
• Patient Weight: 126 LB