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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.Lot number 8931562.
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Event Description
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According to available information, this device snapped.The device was in for three days and it snapped.No other adverse patient effects were reported.
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Manufacturer Narrative
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We have been informed about a defect product, catheter snapped on a folysil silicone.After receiving this complaint, we searched for other complaints and found none regarding the lot number 8931562.Checking the quality databases did not revealed any anomaly in relation to the described defect.We observed that the tap was not well placed.It was placed on the catheter tube, and onto ifu it was recommended to secured the catheter with tape on the catheter part.
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Search Alerts/Recalls
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