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

Model Number REGULAR

Device Problem Material Separation (1562)

Patient Problems Bacterial Infection (1735); Pain (1994); Cramp(s) (2193)

Event Date 08/05/2020

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

Consumer reported she wore a tampon for four to five hours and upon removal the tampon pledget fell apart leaving pieces inside her vaginal cavity.A few days later she began to experience pelvic cramping pain and vaginal odor.She sought medical attention and during a vaginal exam a piece of pledget was found lodged behind her cervix.The pledget piece was removed during the exam and vaginal swabs were also performed.She was diagnosed with bacterial vaginosis and topical metronidazole was prescribed.After the piece of pledget was removed, her odor resolved and the cramping and pain improved.She alleged her menstrual period came a week and a half early.She called her healthcare provider to report her early menstruation and continuous cramping.She stated her healthcare provider prescribed oral metronidazole.She completed the oral antibiotic and her symptoms resolved.

• Brand Name: U BY KOTEX CLICK : 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: 10489317
• MDR Text Key: 206377704
• Report Number: 3003701733-2020-01052
• Device Sequence Number: 1
• Product Code: HEB
• UDI-Device Identifier: 00036000998399
• UDI-Public: 00036000998399
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172118
• 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: 09/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2020
• 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
• Date Manufacturer Received: 08/11/2020
• 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
• Patient Age: 36 YR