MAUDE Adverse Event Report: SCA HYGIENE PRODUCTS TENA INTIMATES INCONTINENCE PADS

Device Problems Product Quality Problem (1506); Patient-Device Incompatibility (2682)

Patient Problem Rash (2033)

Event Date 06/01/2017

Event Type  Injury  

Event Description

Patient called to report adverse reaction to tena incontinence pads.Patient stated she had been using the serenity version, white colored pad for a long time.However, she said she noticed a change in the product approximately two months ago, and this new version was now called serenity.Patient stated that the new version contains dye and perfume which caused her to break out in a rash inside of her legs.Patient said she did speak with the mfr to make them aware of the issue.Patient stated she would like to know if the fda can conduct a test to see if dye is bad for people to hopefully help regulate the use of it in products.

• Brand Name: TENA INTIMATES INCONTINENCE PADS
• Type of Device: TENA INTIMATES INCONTINENCE PADS
• Manufacturer (Section D): SCA HYGIENE PRODUCTS
• MDR Report Key: 6763463
• MDR Text Key: 81814771
• Report Number: MW5071347
• Device Sequence Number: 1
• Product Code: EYQ
• Combination Product (y/n): N
• 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: 08/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR