MAUDE Adverse Event Report: QINGDAO P&B CO., LTD. U BY KOTEX CLICK; TAMPON

Model Number REGULAR

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/01/2014

Event Type  malfunction  

Event Description

The consumer stated that her tampon came apart upon removal and tampon pieces remained inside of her.

Manufacturer Narrative

Device history record could not be reviewed as lot code was not provided by the consumer.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
• Type of Device: TAMPON
• Manufacturer (Section D): QINGDAO P&B CO., LTD.; 40 beijing road; free trade zone; qingdao, 2665 55; CH 266555
• Manufacturer Contact: charnelle thomas ; 1400 holcomb bridge rd.; roswell, GA 30076 ; 6783526031
• MDR Report Key: 3827283
• MDR Text Key: 4500182
• Report Number: 3007303617-2014-00012
• Device Sequence Number: 1
• Product Code: HEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113036
• 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: 04/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: REGULAR
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/24/2014
• 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: 25 YR