MAUDE Adverse Event Report: TROJAN EXTENDED CLIMAX CONTROL CONDOMS

Model Number TJTF-DP-PURPLE-01

Device Problem Labelling, Instructions for Use or Training Problem (1318)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 11/28/2019

Event Type  Injury  

Event Description

My partner and i used trojan extended climax control condoms for the first time and since i'm not used to condoms (every one i've ever used was flavored), i gave him oral with it on.It wouldn't stay on so i just said the heck with it and took it off and kept performing oral on him.After about two mins, i stopped and got really concerned because my entire mouth was numb and after a few more mins it started to sting.We had thrown the box away but checked the wrappers and it didn't say what was the active ingredients so we looked it up online and saw it was benzocaine.I use a compounding pain relieving cream that has lidocaine, prilocaine, and diclofenac in it.I'm guessing the benzocaine, lidocaine, and prilocaine all interacted or i'm allergic to the benzocaine (although i've used (b)(6) before without problems).A couple hours after the incident happened, the tip of my tongue and all around the inside and some of the outside of my mouth was really hurting and had turned white.It hurt to the touch and i couldn't eat that night (b)(6) due to the pain.By midday (b)(6) (not quite 48 hours after it originally happened), the white on the tip of my tongue started to disappear and the pain reduced very slightly and the white inside of my lips started to peel the skin off.The outside of my lips turned a crusty yellow though.The pain half an hour after the incident was about a 5 out of 10, two hours after the incident it was a 7 out of 10, and for the next 35-40 hours was an 8 out of 10.Now that it's ben about 50 hours since the incident, the pain level is about a 6 out of 10.I've also had some mild confusion, lightheadedness, and excess sleepiness that has lasted about 35 hours now and some vomiting about 12 hours after the incident but it only lasted for about an hour.There should have been some kind of label on the wrapper that they had benzocaine in the condoms.Instead, it was on the box and my partner threw the box away without thinking about it.I missed thanksgiving dinner with my family this year because of this.Fda safety report id# (b)(4).

• Brand Name: TROJAN EXTENDED CLIMAX CONTROL CONDOMS
• Type of Device: CONDOM
• MDR Report Key: 9438070
• MDR Text Key: 170119354
• Report Number: MW5091533
• Device Sequence Number: 1
• Product Code: HIS
• Combination Product (y/n): Y
• 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: 12/01/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/01/2021
• Device Model Number: TJTF-DP-PURPLE-01
• Device Catalogue Number: 70015048
• Device Lot Number: TT8331T
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/06/2019
• Patient Sequence Number: 1
• Patient Age: 29 YR
• Patient Weight: 102