Model Number ES29202400 |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problems
Discomfort (2330); Unspecified Kidney or Urinary Problem (4503)
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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 and 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 available information, this device required explantation due to discomfort.The patient developed increasing discomfort in the glans.His urine stream came out at an angle.No other adverse patient effects were reported.
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Manufacturer Narrative
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A titan touch pump, two cylinders and two reservoirs were received for evaluation.As examination of the components may not conclusively confirm or disprove the report of discomfort, quality accepts the physician¿s observations as to the reason for surgical intervention.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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Search Alerts/Recalls
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