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

Model Number SUPER

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/08/2014

Event Type  malfunction  

Event Description

This is a non-us event.The event occurred in (b)(6).The consumer stated that her tampon came apart upon removal and tampon pieces remained inside of her.She was able to remove the remaining pieces.

Manufacturer Narrative

A document and records review was performed on the reported lot.Documentation assessed includes: manufacturing, quality audit, production, raw material and device history records.This assessment found no anomalies that may have attributed to the reported issue; therefore the complaint could not be confirmed.Complaint sample was not returned therefore a product evaluation could not be performed.The cause of the reported complaint could not be determined.Information from this incident will be included in our product complaint and mdr trend analysis.

• 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: 3984643
• MDR Text Key: 20107886
• Report Number: 3007303617-2014-00014
• Device Sequence Number: 1
• Product Code: HEB
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 07/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: SUPER
• Device Lot Number: PB4024AAA1149
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 40 YR