MAUDE Adverse Event Report: ANSELL HEALTHCARE PRODUCTS LLC SKYN CONDOMS, LIFESTYLE

Lot Number 170926021C

Device Problem Insufficient Information (3190)

Patient Problems Hypersensitivity/Allergic reaction (1907); Respiratory Distress (2045)

Event Date 04/20/2018

Event Type  Injury  

Event Description

Skyn condoms has added a "sensual masking agent" (a fragrance product) to their condoms, but as condoms do not require ingredients lists on their products, there is no way for consumers to know this.I have a severe fragrance sensitivity and had trouble breathing when i opened the condom that required using my antihistamines and an inhaler to resolve.Consumers need to know what's in their products and safety data should be available.I contacted the brand and was told that it was patchouli oil (it's not clear if it's natural or synthetic and what, if any, other fragrance chemicals were added to their "masking agent").I work as a sexuality educator and oil-based products and fragrance products are both things that are ill-advised for vaginal usage as they can make some folks more susceptible to vaginal infections.I would like to see all condom packages labeled with an ingredients list moving forward.Who can i contact to discuss this? if my lotion has an ingredients list and it's going inside my body, than surely a product designed for internal use should have a list of ingredients.I do not have any relevant tests, however, the company sent me a lengthy ingredients list that i can share if needed (as well as email correspondence).Is the product over-the-counter? yes; did the problem stop after the person reduced the dose or stopped taking or using the product? yes.Reason for use: as contraception.

• Brand Name: SKYN CONDOMS, LIFESTYLE
• Type of Device: SKYN CONDOMS, LIFESTYLE
• Manufacturer (Section D): ANSELL HEALTHCARE PRODUCTS LLC
• MDR Report Key: 8290225
• MDR Text Key: 134707091
• Report Number: MW5083500
• Device Sequence Number: 1
• Product Code: HIS
• 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: 01/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 05/31/2022
• Device Lot Number: 170926021C
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 30 YR