Model Number ES29182400 |
Device Problems
Migration or Expulsion of Device (1395); Material Protrusion/Extrusion (2979); Migration (4003)
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Patient Problem
Erosion (1750)
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Event Date 01/15/2019 |
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.Once our evaluation is complete, a follow-up report will be submitted.
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Event Description
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According to the available information, erosion/ extrusion - crossover, near extrusion.
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Manufacturer Narrative
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This follow-up mdr is created to document the conclusion of the evaluation.The device was not received for evaluation.As examination of the device may not conclusively confirm or disprove the report of erosion/ extrusion and crossover, near extrusion 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 revealed no trends for this lot.Review of nonconforming reports revealed no nonconformances for this lot.No capas are associated with this lot.
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Search Alerts/Recalls
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