Device Problems
Human Factors Issue (2948); Insufficient Information (3190)
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Patient Problems
Edema (1820); Patient Problem/Medical Problem (2688)
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Event Date 06/01/2016 |
Event Type
Injury
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Manufacturer Narrative
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Prepex is sold and used in (b)(6), it is neither sold nor used in the usa.Receiving reports regarding aes is very challenging and the company makes every effort to gain as much information as possible.The company did not begin reporting any aes to the fda until it was demanded by the fda.As a result there is a gap between the time of the ae and the reporting.This issue will resolve itself during 2017 when the company will report to the fda as required and requested.
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Event Description
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Patient requested early removal due to pain - referred to surgical circumcision.
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Manufacturer Narrative
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Prepex is sold and used in (b)(6), it is neither sold nor used in the usa.Receiving reports regarding aes is very challenging and the company makes every effort to gain as much information as possible.The company did not begin reporting any aes to the fda until it was demanded by the fda.As a result there is a gap between the time of the ae and the reporting.This issue will resolve itself during 2017 when the company will report to the fda as required and requested.No manufacturer investigation was undertaken since this was a foreseen risk in device usage and is clearly noted both in the ifu and the training program.We have attached a copy of the ifu with the relevant text highlighted.Device unavailable.
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Event Description
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Patient requested early removal due to pain - referred to surgical circumcision.
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Search Alerts/Recalls
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