Model Number QSR9181400 |
Device Problem
Material Frayed (1262)
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Patient Problem
No Information (3190)
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Event Date 10/19/2018 |
Event Type
Injury
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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 the available information, patient didn't like pump, too big.Tubing close to pump frayed.The implant is not available for return.
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Manufacturer Narrative
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This follow-up mdr is created to document the conclusion of the investigation.The device is not available 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.Quality reviewed the manufacturing records for this device and confirmed that there were no discrepancies that would have contributed to this complaint and verified that the devices from this lot met all specifications prior to release.A review of the complaint history database revealed no significant trends for lot 2053522.Review of nonconforming reports revealed no nonconformance's for this lot.No capas are associated with this lot.
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Search Alerts/Recalls
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