MAUDE Adverse Event Report: KIMBERLY- CLARK CORP. KOTEX REGULAR ABSORBENCY, U, CLICK COMPACT; TAMPON, MENSTRUAL, UNSCENTED

Lot Number NN012614A 09:32

Device Problems Material Fragmentation (1261); Nonstandard Device (1420)

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

Event Date 07/31/2020

Event Type  Injury  

Event Description

Tampon came apart while taking it out.The center pulled out and came off.I think i got all of it out.If kotex has a known recall for these tampons, why are they still on the store shelves.This is very dangerous.Especially for younger girls that may not know the danger or report it.

• Brand Name: KOTEX REGULAR ABSORBENCY, U, CLICK COMPACT
• Type of Device: TAMPON, MENSTRUAL, UNSCENTED
• Manufacturer (Section D): KIMBERLY- CLARK CORP.
• MDR Report Key: 10361707
• MDR Text Key: 201766420
• Report Number: MW5095866
• Device Sequence Number: 1
• Product Code: HEB
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: NN012614A 09:32
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 38 YR