Model Number AB63221002 |
Device Problem
Material Rupture (1546)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/05/2021 |
Event Type
malfunction
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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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Event Description
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According to the available information, this catheter fell off of the patient.It was noted that the balloon had burst and a replacement with a new catheter was completed.No adverse patient effects were reported.
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Manufacturer Narrative
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Visual examination revealed a slit on the balloon, possibly caused by a weak area in the silicone material.Review of production records did not reveal any anomalies during production.
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Search Alerts/Recalls
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