MAUDE Adverse Event Report: KIMBERLY-CLARK CORPORATION UBYKOTEX, LIBRA; TAMPON, MENSTRUAL, UNSCENTED

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Peeling (1999); Burning Sensation (2146); Blister (4537)

Event Date 06/27/2021

Event Type  Injury  

Event Description

Allergic reaction to latex which i do have a diagnosis of and most companies here in (b)(6) are now using them in period pads (not sure about tampons as i don't use them) and it last month cause me to blister, red skin that peeled, burning sensation all on my vagina and had no choice but continue due to my period present.My latex allergy is getting worse.No package here has any ingredients labeled and i think it should.

• Brand Name: UBYKOTEX, LIBRA
• Type of Device: TAMPON, MENSTRUAL, UNSCENTED
• Manufacturer (Section D): KIMBERLY-CLARK CORPORATION
• MDR Report Key: 12252347
• MDR Text Key: 264481601
• Report Number: MW5102853
• Device Sequence Number: 1
• Product Code: HEB
• Combination Product (y/n): Y
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 31 YR
• Patient Weight: 99