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Model Number AB63221002 |
Device Problem
Burst Container or Vessel (1074)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/16/2020 |
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 available information, this device was tested for inflation and no leak was identified.The catheter was then placed in the patient, but did not hold in place, so it was removed and it was found that the balloon was broken.A new device was ultimately placed successfully and no adverse patient effects were reported.
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Search Alerts/Recalls
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