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Model Number PSMT2030 |
Device Problem
Material Split, Cut or Torn (4008)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Date 11/21/2019 |
Event Type
malfunction
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Manufacturer Narrative
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This mdr is being submitted due to the reported suture pull through that occurred during the initial placement of the acell device.The device was not used and was discarded.Surgeon choose to use an unknown, non-acell device.The patient did not experience any complication due to the suture pull through.The device was not returned to acell for further investigation.A review of the manufacturing records for this lot identified no deviations in the production process that fall outside of specification.The device was manufactured and distributed sterile in compliance with acell's operating procedures and federal, state, and local laws and regulations.
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Event Description
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On"11/2119," acell, inc.Became aware that suture pull through occurred with an acell device during an incisional hernia repair.The device was not used.The surgeon decided to use an unknown, non-acell device which resulted in a surgical delay (increased surgery time).The patient did not experience any complication due to the suture pull through nor the increased surgery time.
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Search Alerts/Recalls
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