U BY KOTEX CLICK TAMPONS

Report

• Report Number: 9611594-2010-00084
• Event Type: Malfunction
• Date Received: November 5, 2010
• Date of Event: October 15, 2010
• Report Date: October 15, 2010
• Manufacturer: AVENT SA DE R.L. DE C.V.
• Product Code: HEB
• PMA / PMN Number: K091749
• Product Problem: Yes
• Report Source: Manufacturer report
• Reporter Location: MI, US
• Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

DEVICE HISTORY RECORD IN REVIEW. CONSUMER DID NOT RETURN PRODUCT FOR EVALUATION.

Description of Event or Problem · 1

CONSUMER INSERTED THE TAMPON AND THE CLEAR PLASTIC PIECE OF THE APPLICATOR REMAINED INSIDE HER WITH THE TAMPON AND SCRATCHED HER. THE TAMPON AND CLEAR PLASTIC PORTION OF THE APPLICATOR HAD TO BE REMOVED BY MEDICAL PERSONNEL.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	U BY KOTEX CLICK TAMPONS	HEB - UNSCENTED MENSTRUAL TAMPON	HEB	AVENT SA DE R.L. DE C.V.	REGULAR	AA006901A0657

Patients

Seq	Age	Sex	Outcome	Treatment
1

Terms

Patient problem · 1

• Tissue Damage

Product problems · 1

• Difficult to Remove

Source type · 1

• Consumer

Type of report · 1

• Initial submission