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

Model Number REGULAR

Device Problem Device Contamination with Body Fluid (2317)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/29/2014

Event Type  malfunction  

Event Description

The consumer stated that her tampon contained a red substance which appeared to be blood.She stated that she purchased the package over a month ago.She opened the carton and removed a tampon sealed in the wrapper.When she opened the tampon warpper, it only contained an applicator which contained a red substance which looked like blood.

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 on 2/5/2014.A visual inspection was performed on the sample.The visual examination observed small red spots on the applicator and click mechanism.The click mechanism was not engaged.Seven companion samples were also inspected, with no defects or abnormalities.A sample was sent to an internal lab and it tested positive for blood.The sample was sent to an outside lab on 2/12/14 to perform additional testing.Evaluation is still in progress.

• 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: 3652548
• MDR Text Key: 15202442
• Report Number: 3007303617-2014-00003
• 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: 01/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: REGULAR
• Device Lot Number: PB3283AAB0314
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2014
• Date Manufacturer Received: 01/29/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2013
• 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: 25 YR