Catalog Number QSR916 |
Device Problems
Crack (1135); Migration (4003)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/26/2023 |
Event Type
Injury
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Event Description
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According to available information, this device required replacement due to a crack.There was a crack in the pump and a herniated reservoir.No other adverse patient effects were reported.
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Manufacturer Narrative
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The lot number was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and 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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Manufacturer Narrative
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The device was not returned for evaluation.Without the benefit of analyzing the device, quality cannot confirm any observations and cannot comment on the condition of the device.If the device becomes available, or additional information is received, quality will re-evaluate this complaint in accordance to procedures.A review of the device history record confirmed the devices from this lot met all specifications prior to release.A review of the complaint history database, nonconformances and capas revealed no trends for this lot.
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Event Description
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According to the available information, the titan otr was revised due to crack in pump and herniated reservoir.
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Search Alerts/Recalls
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