Initial report received by (b)(6), date (b)(6) 2014, reference no.(b)(4).Medical device: durex ultra thin feel condom.Batch details: unknown.Reporter (physician) reported that a female consumer of unknown age developed anaphylaxis to durex ultra thin feel.The patient was not latex allergic, she was however allergic to milk.Outcome: unknown.The company's assessment for this case is possible and unanticipated.Final report: (b)(6) have has been unable to contact the reporter to obtain further information regarding the reported incident, the reporter declined follow up.Supplementary document (b)(4) medical evaluation: durex feel ultra thin condoms.Pdf'.The company's assessment for this case is possible and unanticipated.The company have closed the case.
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Manufacturer narrative: (b)(6) is awaiting further information regarding the reported incident.The labeling states that durex fetherlite ultra condoms are super fine with sensi-fittm for even greater feeling.They are on average 20% thinner than our standard latex condoms while still providing a high level of security and protection.All our latex condoms exceed the iso4074:2002 international quality standard for male natural rubber latex condoms.The company's assessment for this case is possible and unanticipated.Expected date of next report: (b)(4) 2014.Final: (b)(6) have been unable to contact the reporter to obtain further information regarding the reported incident.The reporter declined follow up.A review of previous reports did not highlight any issue, no action required for this incident.Therefore, (b)(6) has decided to close the case.The company's assessment for this case is possible and unanticipated.
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