DUREX Invisible CondomRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00302340912778), received between May 10, 2019 and Nov 15, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Material Fragmentation” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 15, 2019Material Fragmentation; Material Fragmentation

  INITIAL REPORT, RECEIVED DATE 28-OCT-2019. RECEIVED FROM CONSUMER. RELATIONS, (B)(6), (B)(4). MEDICAL DEVICE: DUREX INVISIBLE EXTRA LUBRICATED CONDOMS. BATCH NO: 1000639826. EXPIRY DATE: 31-OCT-2023. CASE REFERENCE NUMBER (B)(4) IS A SPONTANEOUS CASE REPORT SENT BY A CONSUMER WHICH REFERS TO A FEMALE (B)(6). IT WAS REPORTED THAT ON (B)(6) 2019, A (B)(6) FEMALE PATIENT USED DUREX INVISIBLE EXTRA LUBRICATED CONDOMS. PATIENT STATED THAT TWO CONDOMS BROKE DURING INTERCOURSE AND SHE WAS VERY AFRAID BECAUSE THE CONDOM WAS LEFT IN HER AND CAUSED PELVIC INFLAMMATORY DISEASE. THE FIRST BREAKAGE WAS AROUND (B)(6) 2019 AND THE PIECE OF CONDOM WAS INSIDE THE CONSUMER UNTIL (B)(6) 2019. ON (B)(6) 2019 PATIENT WENT TO THE HOSPITAL DUE TO MID-CYCLE BLEEDING, FLUID FROM HER VAGINA, VAGINAL PAIN AND BLADDER PRESSURE. PATIENT INFORMED THAT SHE WAS ADVISED BY THE DOCTOR TO TAKE SOME ANTIBIOTICS TWICE A DAY AFTER SHE WAS DIAGNOSED WITH THE PELVIC INFLAMMATORY DISEASE. PATIENT REPORTED THAT SHE STAYED AT THE HOSPITAL FOR 6 HOURS TO BE TREATED. DURING THE INTERNAL EXAM, DOCTOR PULLED OUT AN APPROXIMATELY ONE-INCH PIECE OF THE CONDOM. SHE WAS TREATED FOR AN INFECTION WITH DOXYCYCLINE AND FLAGYL. THEN AGA

  Patient problems: Abdominal Pain; Abnormal Vaginal Discharge; Foreign Body In Patient; Pelvic Inflammatory Disease; Unspecified Infection

  MAUDE report 9330370 ↗
• InjuryMay 10, 2019Material Fragmentation; Material Fragmentation

  INITIAL REPORT, RECEIVED DATE 03-APR-2019. RECEIVED FROM CONSUMER: RELATIONS, COUNTRY UNITED STATES, REFERENCE NO: (B)(4). MEDICAL DEVICE: DUREX INVISIBLE CONDOM. BATCH NO: 1000578974. EXPIRY DATE: 01-AUG-2023. CASE REFERENCE NUMBER (B)(4) IS A SPONTANEOUS CASE REPORT SENT BY A CONSUMER WHICH REFERS TO A FEMALE AGED 28 YEARS. IT WAS REPORTED THAT ON (B)(6) 2019, A 28-YEAR-OLD FEMALE PATIENT USED DUREX INVISIBLE CONDOM FOR AN UNKNOWN INDICATION. PATIENT STATED THAT SHE HAD USED THE PRODUCT FOR INTERCOURSE. SHE INFORMED THAT DURING INTERCOURSE THE TIP OF THE CONDOM BROKE AND THE PRODUCT WAS REMOVED AND REPLACED WITH A NEW CONDOM WITH NO PROBLEM. SHE ALSO INFORMED THAT ON (B)(6) 2019, SHE FOUND A NICKEL SIZED AMOUNT OF THE CONDOM INSIDE HER VAGINA. SHE SAID THAT IT WAS THE TOP OR TIP OF THE CONDOM. SHE ALSO SAID THAT APPROXIMATELY (B)(6) 2019, SHE STARTED EXPERIENCING THICK VAGINAL DISCHARGE WITH INTERNAL ITCHING. NO HOME THERAPY HAD BEEN COMPLETED. PATIENT REPORTED ON (B)(6) 2019 THAT SHE IS STILL EXPERIENCING DISCHARGE BUT THE ITCHING HAD SUBSIDED. AT THE TIME SHE HAD NOT YET VISITED AN HCP BUT WAS CONCERNED ABOUT POSSIBLY CONTRACTING AN STD. SHE HAS AN IUD INSERTED TO PREVENT PREGN

  Patient problems: Abnormal Vaginal Discharge; Foreign Body In Patient; Itching Sensation; Unspecified Infection

  MAUDE report 8599089 ↗