The patient has disposed of the product, rb is unable to obtain the lot code and complete quality analysis for this incident.The patient did not specify the variety of durex that was used.The patient also did not provide the batch details for the product nor returned any of the remaining unopened product for quality analysis.Therefore, the company is unable to conduct any further investigation at this moment in time.Further information is expected.The product labelling also states that "please read the leaflet inside this pack carefully, especially if you are using condoms for anal or oral sex.No method of contraception can give you 100% protection against pregnancy, hiv or sexually transmitted infections.The company's assessment is serious with a relatedness of unassessable / unclassifiable.Corrective action: no action considered necessary for this incident at this point, the company are currently waiting for follow up information regarding the reported incident.
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Initial report, received date: 27-nov-2017.Received from consumer relations, country: (b)(6).Suspect product: durex unspecified condoms.Batch no and expiry date: not provided.Case reference number (b)(4) is a spontaneous case report sent by a consumer which refers to a male age unknown.It was reported that approximately on (b)(6) 2017, a male patient of an unknown age used durex unspecified condoms, frequency single, dose, indication, route, stop date and duration were all unknown.Patient stated that on ??-???-2017, after the intercourse, he admitted problems with health.Patient reported that he went to a doctor who diagnosed (b)(6) and he had doctor's conclusion about (b)(6).Patient informed that he had thrown the package out and did not remember what type of condoms he used.At the time of reporting, action taken with the suspect drug was unknown and outcome of the case was not recovered.The case was deemed serious because it was classed as medically significant due to (b)(6).No further information was available at the time of report.Case assessment of durex unspecified condoms is as follows: the reported serious assessment has not been provided, case relatedness is possible.The company's assessment is serious with a relatedness of unassessable / unclassifiable and unknown.Case outcome: not recovered / not resolved.
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