MAUDE Adverse Event Report: PROCTER & GAMBLE CO. TAMPAX PEARL TAMPON; TAMPON, MENSTRUAL, SCENTED, DEODORIZED

Model Number TAMPAX PEARL

Device Problems Material Separation (1562); Defective Component (2292)

Patient Problems Device Embedded In Tissue or Plaque (3165); Skin Inflammation/ Irritation (4545)

Event Date 02/15/2021

Event Type  Injury  

Event Description

Tampax pearl tampon's defective, breaking apart, and leaving "smooth removal layer" inside of vagina.This defective tampon has caused severe irritation and possible infection.When i did research for this malfunction, i found that the exact same issue happened in 2018 with the kotex company.I am writing the fda because this is now also a problem with tampax and it has become a serious health risk for women.Fda safety report id # (b)(4).

• Brand Name: TAMPAX PEARL TAMPON
• Type of Device: TAMPON, MENSTRUAL, SCENTED, DEODORIZED
• Manufacturer (Section D): PROCTER & GAMBLE CO.
• MDR Report Key: 11344553
• MDR Text Key: 232905795
• Report Number: MW5099474
• Device Sequence Number: 1
• Product Code: HIL
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 02/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: TAMPAX PEARL
• Device Catalogue Number: 7301071135
• Device Lot Number: 035624300345
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 32 YR
• Patient Weight: 57