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Catalog Number ES2822 |
Device Problems
Device Appears to Trigger Rejection (1524); Improper or Incorrect Procedure or Method (2017); Material Protrusion/Extrusion (2979)
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Patient Problems
Erosion (1750); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/13/2023 |
Event Type
Injury
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Manufacturer Narrative
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The lot number was reviewed for complaint trend, non-conforming 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 extrusion.The cylinder on the device extruded.The doctor reported the patient did not follow the instructions given to him and used the device too soon.No other adverse patient effects were reported.
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Manufacturer Narrative
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H6 codes annex a, e, and d updated.
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Search Alerts/Recalls
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