Durex PleasureMax CondomRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00302340301787), received between Feb 6, 2017 and Feb 6, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Material Rupture” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 6, 2017Material Rupture; Material Rupture

  CASE DESCRIPTION: INITIAL REPORT, RECEIVED DATE: 18-JAN-2017. RECEIVED FROM CONSUMER RELATIONS, COUNTRY: (B)(6), (B)(4). MEDICAL DEVICE: DUREX SETTEBELLO CLASSIC (PRODUCT NOT MARKETED IN USA) BATCH NO AND EXPIRY DATE: NOT PROVIDED. MEDICAL DEVICE: DUREX PLEASUREMAX. (PRODUCT ALSO MARKETED IN USA). BATCH NO AND EXPIRY DATE: NOT PROVIDED. CASE REFERENCE NUMBER (B)(4) IS A REPORT SENT BY A CONSUMER WHICH REFERS TO A MALE AGE UNKNOWN. THE CASE WAS RECEIVED FROM (B)(6). IT WAS REPORTED THAT ON AN UNKNOWN DATE, A MALE PATIENT AGE UNKNOWN USED DUREX SETTEBELLO CLASSIC AND DUREX PLEASUREMAX. HE SAID THAT THE EVENTS HAPPENED AROUND THE END OF (B)(6). HE HAD BEEN USING DUREX FOR LONGER THAN 10 YEARS, MORE OR LESS ALL OF THEM. WHEN THE FIRST EPISODE HAPPENED, HE WAS WEARING A DUREX SETTEBELLO CLASSIC, IT BROKE ALMOST AT THE END OF THE INTERCOURSE RIGHT BEFORE EJACULATING. HE SAID HE HAD ANOTHER EPISODE HAPPENED WITH PLEASURE MAX, IT BROKE DURING INTERCOURSE BUT WITHOUT EJACULATION AT ALL, HE HAD TO DO THE (B)(6) TEST AFTER THREE MONTHS, HE GOT THE RESULT ON (B)(6) 2017, AND IT WAS (B)(6). HE SAID HE CHANGED BRAND BECAUSE DUE TO THIS TWO EPISODES, HE WAS ON TREATMENT FOR HUGE (B)(6). THE COMPA

  Patient problems: Venereal Disease

  MAUDE report 6305811 ↗