Model Number TEC1515 |
Device Problems
Failure To Adhere Or Bond (1031); Product Quality Problem (1506); Mechanics Altered (2984)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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According to the reporter: a mesh was inserted during a tapp procedure and was fixed with glubran (apside).Postoperatively it was discovered that 1 out of 10 times when the surgeon would stick the plate with the glubran it did not stick well.The surgeon thought there was a coating of the plate that was not always identical.
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Manufacturer Narrative
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Additional information was received and this file was determined to not be reportable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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According to the reporter: a mesh was inserted during a tapp procedure and was fixed with glubran (apside).The mesh seemed to be hydrophobic.When the surgeon use glu with the mesh, it seems to be difficult 10% of the time.For him, he thinks meshes are not all the time the same.He thinks that mesh is covered by something which is not uniform.
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Search Alerts/Recalls
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