Model Number E179242400 |
Device Problems
Material Puncture/Hole (1504); Device Damaged by Another Device (2915)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
Injury
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Manufacturer Narrative
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The lot # 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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Event Description
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According to available information, this device required replacement due to a small pin hole in a cylinder close to where the corporotomy was.The thought is that an extra stitch was thrown when closing and hit the implant.No other adverse patient effects were reported.
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Event Description
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According to available information, this device required replacement due to a small pin hole in a cylinder close to where the corporotomy was.The thought is that an extra stitch was thrown when closing and hit the implant.No other adverse patient effects were reported.
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Manufacturer Narrative
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The lot # 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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Search Alerts/Recalls
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