DUREX Performax Intense Condom 00302340853279Recalls & reported problems
Reckitt Benckiser LLC · DUREX Performax Intense Condom 3ct. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00302340853279), received between Nov 22, 2017 and Nov 22, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Device Issue” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Device Issue1
Patient problems
- Hypoxia1
- No Code Available1
- Skin Discoloration1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 22, 2017Device Issue; Device Issue
PATIENT LIPS WERE BLUE [CYANOSIS]. PATIENT DID NOT HAVE ANY FEELING IN MOUTH [HYPOAESTHESIA ORAL] BITTER TASTE [DYSGEUSIA]. CASE DESCRIPTION: RECEIVED FROM CONSUMER RELATIONS, COUNTRY (B)(6), REFERENCE NO: (B)(4). SUSPECT PRODUCT: DUREX PERFORMA CONDOMS. CASE REFERENCE NUMBER DE-(B)(6) IS A SPONTANEOUS CASE REPORT SENT BY A CONSUMER WHICH REFERS TO A FEMALE AGE UNKNOWN. IT WAS REPORTED THAT ON AN UNKNOWN DATE A FEMALE PATIENT OF AN UNKNOWN AGE USED DUREX PERFORMA CONDOMS, FREQUENCY, ROUTE, INDICATION, STOP DATE AND DURATION WERE ALL UNKNOWN. PATIENT STATED THAT HER BOYFRIEND USED THE DUREX PERFORMA CONDOMS FROM THE DUREX FUN EXPLOSION PACK AND DURING INTERCOURSE EVERYTHING WAS FINE. HOWEVER, WHEN WE SPONTANEOUSLY SWITCHED TO ORAL SEX AGAIN, THE BITTER TASTE MADE ME STARTLED. PATIENT'S LIPS WERE BLUE AND SHE DID NOT HAVE ANY FEELING IN HER MOUTH. THE CASE WAS DEEMED SERIOUS BECAUSE IT WAS CLASSED AS MEDICALLY SIGNIFICANT DUE TO CYANOSIS. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF REPORT. CASE ASSESSMENT OF DUREX PERFORMA CONDOMS IS AS FOLLOWS: THE REPORTED SERIOUS ASSESSMENT HAS NOT BEEN PROVIDED, CASE RELATEDNESS IS POSSIBLE. THE COMPANY'S ASSESSMENT IS SERIOUS WITH A RELA
Patient problems: Hypoxia; No Code Available; Skin Discoloration
MAUDE report 7054829 ↗
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- Trojan™ Premium Latex Condoms BareSkin™ Value Pack 00022600998532Church & Dwight CO., Inc. · CONDOM3 reports
- Trojan™ Premium Latex Condoms Magnum™ Large Size Condoms Thin 00022600646143Church & Dwight CO., Inc. · CONDOM2 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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