Model Number ER81252400 |
Device Problem
Positioning Problem (3009)
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Patient Problems
Discomfort (2330); No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
Injury
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Manufacturer Narrative
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The lot number was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.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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Event Description
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According to available information, this device required replacement due to a positioning issue.The cylinders and pump were retained.No other adverse patient effects were reported.
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Event Description
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Additional information received on 10/24/2022: the reason for the repositioning procedure was, according to the physician, that the positioning of the reservoir was bothersome or uncomfortable.
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Manufacturer Narrative
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Correction: clinical sign and symptoms code: e2403 has been corrected to e2311.
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Search Alerts/Recalls
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