Model Number AA61121002 |
Device Problems
Burst Container or Vessel (1074); Insufficient Information (3190)
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Patient Problems
Failure of Implant (1924); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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According to the available information, the catheter was inserted and the balloon burst and the catheter fell off when it was injected with water (15cc).
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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 supplemental reports, a follow-up report will be submitted.
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Manufacturer Narrative
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Visual examination of the returned product confirmed the balloon burst.Possible root cause may be an area of weakness in the silicone material of the balloon.
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Search Alerts/Recalls
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