SKYN CONDOMS, LIFESTYLE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-29 for SKYN CONDOMS, LIFESTYLE manufactured by Ansell Healthcare Products Llc.

Event Text Entries

[134707091] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5083500
MDR Report Key8290225
Date Received2019-01-29
Date of Report2019-01-28
Date of Event2018-04-20
Date Added to Maude2019-01-30
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameSKYN CONDOMS, LIFESTYLE
Generic NameSKYN CONDOMS, LIFESTYLE
Product CodeHIS
Date Received2019-01-29
Lot Number170926021C
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerANSELL HEALTHCARE PRODUCTS LLC


Patients

Patient NumberTreatmentOutcomeDate
10 2019-01-29

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