Model Number 2858201400 |
Device Problems
Break (1069); Detachment Of Device Component (1104)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 01/30/2017 |
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 of 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 the available information, end user said the catheter seems brittle and broke as she inserted it.Thinks that part of it may have broken off inside of her as she can't find the other part of it after she took it out.Has no pain, right now, but is worried about an infection - advised her to go see a doctor.She threw the catheter away.She is not 100% sure that the catheter is still inside her.She thinks that because she can't find the broken piece.All she kept saying was that the catheter broke in half.
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Manufacturer Narrative
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This follow-up mdr was created to document additional information submitted by the end-user.Furthermore, no additional complaints registered about this lot number.The complaints are monitored closely for a forming trend and reported to management on a monthly basis.Production has been informed.There was no ncr for this lot.
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Event Description
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According to the additional information received, customer found that the catheter did not break off inside of her.What she found was that the catheter broke off and went into the packaging and said that if she twists it a certain way, then it breaks.She said that it wasn't the fault of the products.Just the way she twists the catheter and is going to be more careful.
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Search Alerts/Recalls
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