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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].
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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 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 15-apr-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 hsv i and hsv ii, and was undergoing treatment with valcyclovir.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 non-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 outcome: unknown.Follow up report, received date: 13-jun-2019.Received from dso, country: united states.Information added: date of birth: (b)(6) 1990 added.Patient weight added: 194.91 lbs.Lab test "sexually transmitted disease screening" added, result: negative.Units: n/a.Lab test: "pregnancy test" added, result: negative.Units: n/a.Lab test "hsv 1 igg, ab" added, result: 53.10.Units: n/a.Lab test "hsv 2 igg, ab" added, result: 8.60.Units: n/a.Lab test "candida test" added, result: not detected.Units: n/a.Lab test "gardnerella vaginalis" added, result: detected a.Units: n/a.Valacyclovir hydrochloride added as treatment drug.Indication: gardnerella vaginalis.Other relevant history: the patient had examinations: overall: no acute distress.Eyes showed no scleral icterus; hearing was intact and no respiratory issues were reported (normal respiratory effort).No upper extremity cyanosis or skin jaundice was present.Patient was awake and alert, with appropriate behaviour and no obvious cranial nerve deficits.Patient's speech was intact.Medical records were provided by the consumer's hcp.They confirmed the patient visited their hcp on (b)(6) 2019 reporting the tip of the condom was left inside her vagina, and she was experiencing a white discharge.The physical exam confirmed the patient had an iud and no rash, lesions or bumps were noted on her pelvic exam.The patient self treated her symptoms with monistat and had no history of sexually transmitted diseases.A sexually transmitted disease screening was completed.The patient had a follow up visit on (b)(6) 2019.Results of a pregnancy test previously taken were confirmed as negative.The patient had a positive diagnosis of gardnerella vaginalis.As the reporter was able to provide details of the product used by the consumer rb were able to investigate the reported issue.Reviewing the process records and release testing results recorded at the point of manufacture, however the consumer did not provide the implicated sample.Results of the investigation failed to identify any issues and no root cause for the breakage could be determined.The consumer provided no further information.Rb is awaiting global production values for these products for completion of the medical device evaluation report.Follow up has been requested to obtain further information.This case has been deemed serious due to device breakage.The company's assessment is serious with a relatedness of possible and unanticipated.Case outcome: unknown.Evaluation summary: the review of analytical record shows the batch complies to the release requirement as per iso 4074.Samples tested: 315 pcs.Non-conforming samples: 0 pc (limit: not more than 10 pcs).Av.Burst pressure: 1.500kpa.Av.Burst volume: 40.50l.The test for burst properties of retention samples complies to iso4074 requirement.Samples tested: 125 pcs.Non-conforming samples: 0 pc (limit: not more than 5 pcs).Av.Burst pressure: 1.500kpa.Av.Burst volume: 34.50l.Gardnerella vaginalis [vaginitis gardnerella].
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