Model Number QNR9181022 |
Device Problems
Leak/Splash (1354); Material Split, Cut or Torn (4008)
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Patient Problem
No Information (3190)
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Event Date 11/19/2019 |
Event Type
Injury
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Manufacturer Narrative
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The lot number was reviewed for complaint trend, nonconforming report and capa review.No trends were noted.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 the available information, the pump was replaced due to a pump tubing leak and tear.
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Event Description
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Additional information received indicated that the pump tubing leaked due to an observed tear in the reservoir tubing near the strain relief.
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Manufacturer Narrative
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This follow-up was created to document the additional event information.The device was not received for evaluation.Without the benefit of analyzing the device quality cannot confirm any observations or comment on the condition of the product.If the device becomes available, or additional information is received, the complaint will be re-evaluated according to procedures.
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Search Alerts/Recalls
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