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

Device Problem Material Separation (1562)

Patient Problem Bacterial Infection (1735)

Event Date 01/07/2019

Event Type  malfunction  

Manufacturer Narrative

A brand name, model, udi or manufacturer lot code were not provided.With no means to determine the manufacturer/asset line and day of production, no further investigation on documents and supporting records can be performed.

Event Description

Consumer¿s mother reported the string pulled out of a tampon upon removal leaving the tampon inside.The daughter was able to manually remove the tampon but sought medical attention to ensure all of the tampon was removed.During the me.During the medical exam the consumer was diagnosed with a bacterial vaginosis.

• 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: 9445778
• MDR Text Key: 178360844
• Report Number: 3011109575-2019-01616
• Device Sequence Number: 1
• Product Code: HEB
• 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: 12/10/2019

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/07/2019
• Initial Date FDA Received: 12/10/2019
• 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
• Patient Age: 17 YR