The lot number was reviewed for complaint trend, nonconforming reports and capa review.No trends were noted.Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.
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According to the available information, this is a (b)(6)-year-old male with a complicated history, however, recently underwent removal, replacement of a non -coloplast penile implant with a circumcision and presents with auto inflation and scrotal swelling concerning for infection.The inflatable device was explanted and replaced with a malleable device.Previous to surgery, pt was seen in er for skin dehiscence two weeks prior.Reported difficulty with deflation and that the pump autoinflates without manipulation.Reported swelling and pain of scrotum and penis.
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