Model Number ES28222400 |
Device Problems
Mechanical Jam (2983); Pumping Problem (3016)
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Patient Problem
No Information (3190)
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Event Date 07/17/2019 |
Event Type
Injury
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Manufacturer Narrative
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The device has been received at coloplast; however the evaluation is not yet complete.Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Once our evaluation is complete, a follow-up report will be submitted.
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Event Description
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According to the available information, hard pump.
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Event Description
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Additional information indicated the issue was observed shortly after implantation.
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Manufacturer Narrative
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This follow-up mdr is created to document the evaluation of the returned device and the additional event information.A titan touch pump was received.Examination and testing of the returned pump noted abrasion on all tubes.No functional abnormalities were noted with the pump.The information received indicated a hard pump, but because no functional abnormalities were noted with the returned components, quality cannot confirm the complaint as reported.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, nonconformance's and capas revealed no trends for this lot.
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Search Alerts/Recalls
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