Model Number ES28222400 |
Device Problem
Pumping Problem (3016)
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Patient Problem
No Information (3190)
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Event Date 12/18/2019 |
Event Type
Injury
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Manufacturer Narrative
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The lot number was reviewed for complaint trend, nonconforming reports and capa review.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, the pump was malfunctioning.It was noted that the device would not pump up.Another inflatable device was implanted.
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Manufacturer Narrative
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This follow-up mdr is created to document the evaluation of the returned device.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.A titan touch pump was the sole component received for evaluation.The inlet tube with connector was detached for testing.Examination and testing of the returned component revealed abrasion on all pump tubes.No functional abnormalities were noted with the pump or detached inlet tube with connector.The information received indicated the device malfunctioned, but because no functional abnormalities were noted with the returned component, the complaint could not be confirmed as reported.
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Search Alerts/Recalls
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