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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.The device broke at the y connection of the balloon and urine drainage port from the rest of the device.It appears that it may have been caught while putting the x-ray board behind the patient although no tugging or resistance was felt underneath the patient.After the board was removed, the nurse observed that the urinary catheter had snapped near the port.They report that there was no obvious snagging or disruption which caused the snap, but it was not observed so they are unable to say if it got caught.Remainder of urinary catheter removed easily.
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Search Alerts/Recalls
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