Catalog Number ES8920 |
Device Problem
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 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 replacement due to size.A narrow model was implanted.No other adverse patient effects were reported.
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Event Description
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According to available information, this device required replacement due to size.A narrow model was implanted.No other adverse patient effects were reported.
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Manufacturer Narrative
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A titan pump and two cylinders were received.Because examination of the returned components may not conclusively confirm or disprove the report of incorrect sizing, a microscopic examination was not performed.Based on the information provided quality accepts the physician¿s observations of such as the reason for surgical intervention.A review of the device history record confirmed the devices from this lot met all specifications 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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Search Alerts/Recalls
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