MAUDE Adverse Event Report: ANSELL HEALTHCARE PRODUCT LLC. LIFESTYLE SKYN FEEL EVERYTHING ORIGINAL 12 NON-LATEX LUBRICATED CONDOM

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Itching Sensation (1943)

Event Date 12/03/2017

Event Type  Injury  

Event Description

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.

• Brand Name: LIFESTYLE SKYN FEEL EVERYTHING ORIGINAL 12 NON-LATEX LUBRICATED CONDOM
• Type of Device: CONDOM
• Manufacturer (Section D): ANSELL HEALTHCARE PRODUCT LLC.
• MDR Report Key: 7525433
• MDR Text Key: 108906759
• Report Number: MW5077299
• Device Sequence Number: 2
• 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: 05/16/2018
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR
• Patient Weight: 84