TAMPAX TAMPONS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-07-25 for TAMPAX TAMPONS manufactured by Procter & Gamble.

Event Text Entries

[2124678] Pt called to state some time in the month of (b)(6), she bought (b)(6) tampons from (b)(6). When she got home, she realized the package was open but thought that the seal wasn't good on packages anyway. After using the tampons, pt states she had a reaction of burning, itching, pain, irritation and she states that upon wiping her vaginal area "it felt like razor blades". Pt states she went to her doctor and was prescribed estrogen cream. A few weeks later, pt was going swimming, used the tampons from the same unsealed box and experienced intense, itching, burning and redness. Pt says she has one tampon left from the unsealed box and noticed there are holes in the tampon wrapper itself. Pt wants to know where she can get this tested to see if any animal exposure or other contaminates have come in contact with this product. Pt has already contacted manufacturer which told her she is probably having a reaction to product. Pt is to follow-up with her doctor.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5021464
• MDR Report Key: 2177377
• Date Received: 2011-07-25
• Date of Report: 2011-07-25
• Date of Event: 2011-06-01
• Date Added to Maude: 2011-08-02
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: TAMPAX TAMPONS
• Generic Name: NONE
• Product Code: HIL
• Date Received: 2011-07-25
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: PROCTER & GAMBLE

Patients

Patient Number	Treatment	Outcome	Date
1	0		2011-07-25