Catalog Number ER8125 |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/18/2023 |
Event Type
Injury
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Manufacturer Narrative
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The lot number was reviewed for complaint trend, non-conforming 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 migration.Only the reservoir was replaced.No other adverse patient effects were reported.
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Manufacturer Narrative
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The device was not returned for evaluation.However, because examination of the returned components may not conclusively confirm or disprove the report of reservoir migration, 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.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 titan reservoir was revised due to migration.
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Search Alerts/Recalls
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