Model Number ES29182400 |
Device Problems
Migration or Expulsion of Device (1395); Extrusion (2934)
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Patient Problems
Erosion (1750); No Information (3190)
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Event Date 12/11/2017 |
Event Type
Injury
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Manufacturer Narrative
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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 of 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, erosion/extrusion.
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Manufacturer Narrative
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This follow-up mdr is created to document the conclusion of the investigation.A reservoir was the sole component received.Because qa's examination may not conclusively confirm or disprove the report of herniation, 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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Search Alerts/Recalls
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