Catalog Number 606-907-001 |
Device Problem
Material Integrity Problem (2978)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
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Event Description
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A facility reported that when the medical staff opened the surgimend, they noticed that the edge was hard.They then rehydrated the product in room temperature saline water and noticed that there was excessive powder in the water and that there were filaments of tissue detached from the mesh which became fragile and friable while stretching and it broke up.No patient contact/injury reported and the event led to 35 minutes surgical delay.
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Manufacturer Narrative
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The surgimend mesh was returned for evaluation: the device was received to be degraded in a way that prevents evaluation/investigation of the alleged defect.Failure analysis could not be completed, root cause can not be determined at this time.Manufacturing records demonstrate that the device met specifications.A root cause can not be determined.This conclusion was made as the device received degraded far past the original state that the complaint was observed in.This type of defect can occur as a result of inadequate handling of the product, specifically during the hydration phase, however this can not be confirmed in this case.
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Event Description
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N/a.
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Search Alerts/Recalls
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