Catalog Number ES8816 |
Device Problems
Off-Label Use (1494); Inadequacy of Device Shape and/or Size (1583)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/14/2023 |
Event Type
Injury
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Manufacturer Narrative
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The lot number was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release.No trends were noted for complaints and there were no nonconforming reports or capas that were confirmed to be associated.
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Event Description
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According to the available information the implant was explanted and replaced due to sizing / patient preference.
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Manufacturer Narrative
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It was noted this was a transgender case.Per the instructions for use (ifu), quality does not recommend the use of products in an off-label manner.The titan touch inflatable penile prosthesis is indicated for male patients suffering from erectile dysfunction (impotence) who are considered to be candidates for implantation of a penile prosthesis.A review of the device history record confirmed the devices from this lot met all specifications prior to release.A review of the complaint history database, nonconformances and capas revealed no trends for this lot.
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Event Description
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According to the available information the implant was explanted and replaced due to sizing / patient preference.It was noted this was a transgender case.
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Search Alerts/Recalls
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