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Model Number AA71081002 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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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 required replacement due to a break.While repositioning the patient the device snapped.There was a clean snap across and above the balloon port.The balloon was unable to deflate as the port had been snapped clean from the device tip.The balloon was found to be deflated therefore device was removed and no harm caused.Nurse in charge notified and new urinary device was placed.
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Search Alerts/Recalls
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