Model Number ESR9182400 |
Device Problems
Inadequacy of Device Shape and/or Size (1583); Positioning Problem (3009)
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Patient Problem
Scarring (2061)
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Event Date 01/24/2019 |
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, pump removed due to improper placement/scared in and tubing too short.Touch pump placed in new position for better placement.
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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 improper placement, 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, nonconformances and capas revealed no trends for this lot.
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Search Alerts/Recalls
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