Device Problem
Stretched (1601)
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Patient Problems
Pain (1994); Scarring (2061); Discomfort (2330); Prolapse (2475)
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Event Type
Injury
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Manufacturer Narrative
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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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Event Description
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According to the available information, the patient had surgery for bladder prolapse with restorelle y.After less than three months, the mesh had stretched.It was reported that the patient's new surgeon knew how to remove it and replace it and also repair the scarring.The patient was experiencing severe pain so the mesh was explanted.A non-coloplast mesh was implanted.The surgery and recovery were painful.The patient is no longer experiencing pain.
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Manufacturer Narrative
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This follow-up mdr is created to document the additional event information received.
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Event Description
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Additional information indicated a few months after implant the patient's prolapse was back.The patient reported discomfort and pain.
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Search Alerts/Recalls
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