MAUDE Adverse Event Report: K-C AFC MANUFACTURING, S. DE R.L. DE C.V U BY KOTEX SLEEK : TAMPON, MENSTRUAL, UNSCENTED : HEB

Model Number REGULAR

Device Problem Material Separation (1562)

Patient Problem Bacterial Infection (1735)

Event Date 12/07/2018

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

Consumer reported that upon pulling the string, tampon unraveled and there was cotton left inside her.She saw primary care physician and was diagnosed with bacterial infection.Consumer was prescribed with antibiotics and her health has improved now.

• Brand Name: U BY KOTEX SLEEK : TAMPON, MENSTRUAL, UNSCENTED : HEB
• Type of Device: TAMPON, MENSTRUAL, UNSCENTED
• Manufacturer (Section D): K-C AFC MANUFACTURING, S. DE R.L. DE C.V; calzada industrial de las maquiladoras #87; nuevo nogales; nogales, sonora mexico 84094 ; MX 84094
• Manufacturer (Section G): K-C AFC MANUFACTURING, S. DE R.L. DE C.V; calzada industrial de las maquiladoras #87; nuevo nogales; nogales, sonora mexico 84094 ; MX 84094
• Manufacturer Contact: emily arnould, rn bsn ; 2100 winchester rd; neenah, WI 54956 ; 9207213128
• MDR Report Key: 9426722
• MDR Text Key: 177253646
• Report Number: 3011109575-2019-01553
• Device Sequence Number: 1
• Product Code: HEB
• UDI-Device Identifier: 00036000998368
• UDI-Public: 00036000998368
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112635
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: REGULAR
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/05/2019
• Initial Date FDA Received: 12/06/2019
• 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