MAUDE Adverse Event Report: PROCTER & GAMBLE CO. TAMPAX; TAMPON, MENSTRUAL, UNSCENTED

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Itching Sensation (1943)

Event Date 08/15/2022

Event Type  Injury  

Event Description

We stopped at a (b)(6) to fuel because i go on the road with my husband.I did not pack enough pads and i needed to buy some.They only had the tampax brand tampons, so i grabbed whatever was available until we can get to where they are in stock.That was around 2pm and by that night i started to itch in my hands first.Then it started traveling horribly, one part of my body would itch then another and it kept happening all the way to (b)(6) 2022, i woke up because the itch was unbearable and i dug everywhere to then thank god find an extra pad.It's (b)(6) 2022 almost 5pm and the itch continues to travel through each section of my body.

• Brand Name: TAMPAX
• Type of Device: TAMPON, MENSTRUAL, UNSCENTED
• Manufacturer (Section D): PROCTER & GAMBLE CO.
• MDR Report Key: 15250517
• MDR Text Key: 298376908
• Report Number: MW5111571
• Device Sequence Number: 1
• Product Code: HEB
• 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: 08/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 31 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic