Model Number ES28182400 |
Device Problems
Crack (1135); Leak/Splash (1354)
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Patient Problem
No Information (3190)
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Event Date 09/25/2019 |
Event Type
Injury
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Manufacturer Narrative
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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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Event Description
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According to the available information, penile implant malfunction, potential leak was reported.After removal of the the implant, clear split was found in the tubing at the juntion where tubing entered the corpora.Both cylinders were replaced, the reservoir and pump remained implanted.
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Manufacturer Narrative
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The follow-up was created to document the medwatch (mw5090974) form being received.
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Manufacturer Narrative
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This follow-up was created to document the corrected implant date and code.
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Search Alerts/Recalls
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