Catalog Number UMM3 |
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 03/13/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.The product upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.
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Event Description
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It was reported that the patient underwent a hernia repair procedure on (b)(6) 2017 and the mesh was implanted.During the procedure, the mesh package was in torn down the side and was no longer sterile.Another like device was used to complete the procedure with no patient consequences reported.No further information is available.
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Manufacturer Narrative
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We received the actual sample.The cause of tearing of the foil could not be clarified.In order to avoid foil breakage during opening the user should try to open slowly at the beginning and pull the flap down separating both (during holding each flap between the thumb and forefinger of the right hand and left hand).
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Search Alerts/Recalls
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