MAUDE Adverse Event Report: KIMBERLY-CLARK CORP U TAMPONS REGUAL KOTEX; PAD, MENSTRUAL, UNSCENTED

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Sepsis (2067); Toxic Shock Syndrome (2108)

Event Date 03/08/2018

Event Type  Injury  

Event Description

Sepsis toxic shock.Is the product over-the-counter? yes.Did the problem stop after the person reduced the dose or stopped taking or using the product again? doesn't apply.Do you still have the product in case we need to evaluate it? no.

• Brand Name: U TAMPONS REGUAL KOTEX
• Type of Device: PAD, MENSTRUAL, UNSCENTED
• Manufacturer (Section D): KIMBERLY-CLARK CORP
• MDR Report Key: 8320810
• MDR Text Key: 135889250
• Report Number: MW5083853
• Device Sequence Number: 1
• Product Code: HHD
• 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: 02/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 41 YR