Catalog Number PMSK1 |
Device Problem
Tear, Rip or Hole in Device Packaging (2385)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/06/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
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Event Description
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It was reported that during a hernia repair procedure, the outer paper package was torn and the mesh slipped outside the box through this tear.The procedure was completed using a like device.There were no adverse consequences for the patient reported.No additional information is available.
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Manufacturer Narrative
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It was observed that the folder side tabs were not folded.This can result on product out of its primary packaging (folder), however the mesh and the folder were inside a sealed pouch (secondary packaging).Product integrity will not be affected by the defect observed.
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Search Alerts/Recalls
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