Model Number ES88202400 |
Device Problem
Positioning Problem (3009)
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Patient Problem
Deformity/ Disfigurement (2360)
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Event Date 04/19/2022 |
Event Type
Injury
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Event Description
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According to available information, this device was explanted and replaced due to improper pump placement causing supersonic transporter (sst) deformity.No other adverse patient effects were reported.
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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 or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.
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Manufacturer Narrative
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A titan pump, reservoir and two cylinders received for evaluation.As examination of the components may not conclusively confirm or disprove the report of malposition and sst deformity, 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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