Model Number ES29202400 |
Device Problem
Structural Problem (2506)
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Patient Problem
Pain (1994)
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Event Date 01/02/2019 |
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.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, pain, complaint of buckling.
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Manufacturer Narrative
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This follow-up mdr is created to document the conclusion of the evaluation.A titan touch pump and two cylinders were received for evaluation.Examination of the returned components revealed no abnormalities that would have contributed to the report of pain and buckling.However, because quality's examination of the returned components may not conclusively confirm or disprove the report of pain and buckling, quality accepts the physician's observations of such as the reason for surgical intervention.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 6157443.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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