[144680273]
Case reference number (b)(6) is a spontaneous case report sent by a consumer which refers to a female aged (b)(6) years. It was reported that on (b)(6) 2019, a (b)(6) 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 pregnancy. On (b)(6) 2019 the patient confirmed she did visit a hcp and is awaiting unspecified test results; the discharge is still present. Her hcp took a blood sample and vaginal swab; patient reported she currently was taking no treatment. The reporter provided more information on (b)(6) 2019. She states that on (b)(6) 2019 she saw her hcp and had an std screening and pregnancy test. The std screening came back positive for an unspecified sexually transmitted disease. The patient stated that bacteria was found and she was completing unspecified treatment. Her hcp did not confirm if her symptoms were related to the product. Patient stated she had a test for gardnerella vaginalis which was positive, this was been treated by metrogel. The patient also confirmed she had (b)(6), and was undergoing treatment with (b)(6). It was not confirmed if this occurred before or after device usage. Rb is awaiting the medical records from the consumer. Medical history: allergic to perfume and smoker. The case was deemed serious. Follow-up has been requested to obtain further information. The company's assessment is serious with a relatedness of possible and unanticipated. Case description: 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. Vaginal discharge [vaginal discharge]. Internal itching [pruritus genital]. Patient found nickel sized amount of the condom inside her vagina [foreign body in reproductive tract]. Condom broke [device breakage]. Positive std screening [sexually transmitted disease]. Gardnerella vaginalis [vaginitis gardnerella].
Patient Sequence No: 1, Text Type: D, B5