MAUDE Adverse Event Report: KIMBERLY-CLARK CORPORATION U BY KOTEX UNKNOWN : TAMPON, MENSTRUAL, UNSCENTED : HEB

Device Problems Material Fragmentation (1261); Material Separation (1562)

Patient Problem Pain (1994)

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

A manufacturer lot code was not provided.With no means to ascertain the manufacturer/asset line and day of production, no further investigation on documents and supporting records can be performed.

Event Description

This is a non-us event.This occurred in (b)(6).Consumer reported she inserted a tampon and it was very painful.After insertion the tip of the applicator looked like it had ripped off.She then tried to remove the tampon and the string came off.She was able to manually remove the tampon and upon removal small pieces of green plastic from the applicator were on the tampon.Multiple attempts have been made to obtain further information however no further information has been received.

• Brand Name: U BY KOTEX UNKNOWN : TAMPON, MENSTRUAL, UNSCENTED : HEB
• Type of Device: TAMPON, MENSTRUAL, UNSCENTED
• Manufacturer (Section D): KIMBERLY-CLARK CORPORATION; 2100 winchester rd.; neenah WI 54956
• Manufacturer (Section G): KIMBERLY-CLARK CORPORATION; 2100 winchester rd.; neenah WI 54956
• Manufacturer Contact: emily arnould, rn bsn ; 2100 winchester rd; neenah, WI 54956 ; 9207213128
• MDR Report Key: 9672902
• MDR Text Key: 177847838
• Report Number: 3003701733-2020-00147
• Device Sequence Number: 1
• Product Code: HEB
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1