Catalog Number EJ10G03 |
Device Problem
Tear, Rip or Hole in Device Packaging (2385)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Code Available (3191)
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Event Date 02/05/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Conclusion: to date, the device has not been returned.If the product is returned for evaluation, any further info derived from the evaluation will be submitted in a supplemental 3500a form.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 a patient underwent a gynecological procedure and suture was used.During the procedure, it was noted that there were several pin holes in the packaging.There were no adverse patient consequences reported.
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Manufacturer Narrative
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Conclusion: the actual sample was returned for evaluation.Visual examination revealed holes at the returned foil.The holes were located in an area where the actual foil shows a multitude of wrinkles caused by foil opening.In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
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Search Alerts/Recalls
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