U BY KOTEX

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-23 for U BY KOTEX manufactured by Kimberly-clark Corp.

MAUDE Entry Details

• Report Number: MW5088347
• MDR Report Key: 8822910
• Date Received: 2019-07-23
• Date of Report: 2019-07-19
• Date of Event: 2019-06-28
• Date Added to Maude: 2019-07-24
• 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: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Sequence Number: 1

• Brand Name: U BY KOTEX
• Generic Name: TAMPON, MENSTRUAL, UNSCENTED
• Product Code: HEB
• Date Received: 2019-07-23
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: KIMBERLY-CLARK CORP

Device Sequence Number: 2

• Brand Name: TAMPAX PEARL
• Generic Name: TAMPON, MENSTRUAL, UNSCENTED
• Product Code: HEB
• Date Received: 2019-07-23
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: PROCTER AND GAMBLE CO

Device Sequence Number: 3

• Brand Name: PLAYTEX SPORT
• Generic Name: TAMPON, MENSTRUAL, UNSCENTED
• Product Code: HEB
• Date Received: 2019-07-23
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: PLAYTEX MANUFACTURING INC.

Device Sequence Number: 4

• Brand Name: ALWAYS
• Generic Name: PAD, MENSTRUAL, UNSCENTED
• Product Code: HHD
• Date Received: 2019-07-23
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 4
• Device Event Key: 0
• Manufacturer: PROCTER AND GAMBLE CO

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Life Threatening; 2. Other	2019-07-23