Model Number ES28162400 |
Device Problems
Inadequacy of Device Shape and/or Size (1583); Malposition of Device (2616); Deformation Due to Compressive Stress (2889)
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Patient Problem
No Information (3190)
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Event Date 09/12/2018 |
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, short and not placed well; also possible tubing kinked (difficulty pumping).
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Manufacturer Narrative
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This follow-up mdr is created to document the conclusion of the evaluation.Quality was unsuccessful in securing the device for evaluation.Without the benefit of analyzing the device, quality cannot confirm any observations and cannot comment on the condition of the device.Quality reviewed the manufacturing records for this device and confirmed that there were no discrepancies that would have contributed to this complaint and verified that the devices from this lot met all specifications prior to release.Review of nonconforming reports revealed no nonconformance with this lot that would have contributed to the event.A review of the complaint database revealed no significant trends in complaints of this type for lot 4979189.The most likely root cause of the event cannot be determined at this time.If the device or additional information is received, quality will re-evaluate this event in accordance with procedures.
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Search Alerts/Recalls
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