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

Device Problem Device Contamination with Body Fluid (2317)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/28/2019

Event Type  Injury  

Event Description

I purchased a box of tampax tampons at (b)(6) used a few and they were fine then i opened one and the applicator to the tampon had someone's dried blood on it.Completely disgusting and needs to be recalled.I have photos, i have already contacted tampax and an attorney.Document: (b)(6).Report number: (b)(6).Purchase date: (b)(6) 2019.

• Brand Name: TAMPAX
• Type of Device: TAMPON, MENSTRUAL, SCENTED DEODORIZED
• Manufacturer (Section D): PROCTER AND GAMBLE CO.
• MDR Report Key: 8922641
• MDR Text Key: 155346834
• Report Number: MW5089237
• Device Sequence Number: 1
• Product Code: HIL
• 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: 07/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 38 YR