LIFESTYLE SKYN FEEL EVERYTHING ORIGINAL 12 NON-LATEX LUBRICATED CONDOM 7312

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-17 for LIFESTYLE SKYN FEEL EVERYTHING ORIGINAL 12 NON-LATEX LUBRICATED CONDOM 7312 manufactured by Ansell Healthcare Product Llc..

Event Text Entries

[108906759] On (b)(6) 2017, i ordered online at (b)(6) and then received, on (b)(6) 2017, three (3) boxes of ansell lifestyles skyn feel everything original natural feeling for skin-to-skin sensation 12 non-latex lubricated condoms, (b)(4), lot 171024031c, exp: 09/30/2021, product of (b)(4), mfd, for ansell healthcare products, llc. , (b)(4), because such condom brand and type was display-advertised as "non-latex. " in the past, other brands of condoms that i had tried were labeled as "latex" and not only made me itchy but also broke in my masturbation rubbery sleeve, a certain sex toy which i had already ordered online and then received from (b)(6). When i tried one of such same ansell skyn condoms in such same sleeve of mine, such condom did not break at all. Immediately and for several hrs after my own such same use of such same condom, however, my own testicular sac skin had become and then remained severely itchy. Then, through an ansell. Com customer complaint email address, i complained about such matter to ansell, which then mailed me a letter, dated january 31, 2018, an envelope from (b)(4) of consumer relations instructing me to return such condom package unused, contents back to ansell in such same supplied envelope. Later, i received through (b)(6) mail, three (3) boxes of three (3) count each of such very same brand and type of ansell skyn condoms, none of which i tried. Then, i requested of ansell a retail consumer supply of such same kind of non-latex, strong condom but, instead of such condom typical style of lubricated, in a brand new non-lubricated style, so that, instead of becoming itchy, i can add my own preferred anal, not vaginal, lubricant. Ansell, however, has not provided me with any of such type of condom. Likewise, i continue remaining, unfortunately, devoid of any intimacy with anybody, but i am single, gay liberal christian man wanting to experience intimacy through first seeking, then finding, and finally, thoroughly enjoying my own legally same-sex safe, comfortable, and fulfilling marriage to a loving man. For me to experience intimacy, how do i purchase my own non-latex, extra-strong, non-lubricated condoms.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5077299
MDR Report Key7525433
Date Received2018-05-17
Date of Report2018-05-16
Date of Event2017-12-03
Date Added to Maude2018-05-18
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 Sequence Number: 1

Brand NameLIFESTYLE SKYN FEEL EVERYTHING ORIGINAL 12 NON-LATEX LUBRICATED CONDOM
Generic NameCONDOM
Product CodeHIS
Date Received2018-05-17
Model Number7312
Lot Number171024031C
OperatorLAY USER/PATIENT
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerANSELL HEALTHCARE PRODUCT LLC.

Device Sequence Number: 2

Brand NameLIFESTYLE SKYN FEEL EVERYTHING ORIGINAL 12 NON-LATEX LUBRICATED CONDOM
Generic NameCONDOM
Product CodeHIS
Date Received2018-05-17
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No2
Device Event Key0
ManufacturerANSELL HEALTHCARE PRODUCT LLC.

Device Sequence Number: 3

Brand NameLIFESTYLE SKYN FEEL EVERYTHING ORIGINAL 12 NON-LATEX LUBRICATED CONDOM
Generic NameCONDOM
Product CodeHIS
Date Received2018-05-17
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No3
Device Event Key0
ManufacturerANSELL HEALTHCARE PRODUCT LLC.


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-05-17

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