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

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Toxic Shock Syndrome (2108)

Event Date 04/01/2020

Event Type  Injury  

Event Description

Tss ( toxic shock syndrome ); tampon unraveling after use.Fda safety report id# (b)(4).

• Brand Name: TAMPON TAMPAX (P&G)
• Type of Device: TAMPON, MENSTRUAL, UNSCENTED
• Manufacturer (Section D): PROCTER & GAMBLE CO.
• MDR Report Key: 9933303
• MDR Text Key: 186774898
• Report Number: MW5094051
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other; Disability
• Patient Age: 19 YR
• Patient Weight: 46