MAUDE Adverse Event Report: AVENT S. DE R.L. DE C.V. U BY KOTEX CLICK : TAMPON, MENSTRUAL, UNSCENTED : HEB

Model Number REGULAR

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/19/2014

Event Type  malfunction  

Event Description

Consumer stated tampon fell apart inside her when she went to remove the tampon.She states the she pulled the tampon string and outer covering came out and she had pieces stuck in her vagina.The consumer went to her health care provider to get it removed and was prescribed an antibiotic.This is a non-us event.The event occurred in (b)(6).

Manufacturer Narrative

Device history record is under review.Information from this incident will be included in our product complaint and mdr trend analysis.Consumer had not returned unused product for evaluation at the time of this report.

• Brand Name: U BY KOTEX CLICK : TAMPON, MENSTRUAL, UNSCENTED : HEB
• Type of Device: TAMPON, MENSTRUAL, UNSCENTED
• Manufacturer (Section D): AVENT S. DE R.L. DE C.V.; circuito industrial no.40; colonia obrera; nogales 8404 8; MX 84048
• Manufacturer Contact: jean nielsen ; 2100 winchester rd.; neenah, WI 54956 ; 9207216517
• MDR Report Key: 4113872
• MDR Text Key: 15366356
• Report Number: 9611594-2014-00083
• Device Sequence Number: 1
• Product Code: HEB
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PK113036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: REGULAR
• Device Lot Number: AA412201B
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2014
• 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: 26 YR