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Catalog Number UNK STRATTICE |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Wound Dehiscence (1154); No Information (3190)
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Event Date 03/15/2018 |
Event Type
Injury
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Manufacturer Narrative
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Results - the explanted device was returned to lifecell for evaluation in formalin solution.Based upon a visual inspection, the device was observed to have scattered brown and yellow material on the surface, which appears to be biological in nature.Six sutures were present and intact on the upper portion of the device and the bottom left hand corner appeared to have been surgically cut.No other defects or irregularities were observed.The device was fully intact with no signs of degradation.The lot number remains unknown; therefore a review of the device history records could not be performed.Conclusion - multiple attempts have been made by the distributor to gather additional information from the surgeon about the nature of the complaint, lot number, and dates.At this time, no further information has been provided.This event is being reported in caution based on the report from the distributor that the device was explanted.Based on a visual inspection of the device alone, a nonconformance was not confirmed.If additional information is received, a follow up report will be submitted.No further actions are required at this time.
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Event Description
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Limited information was reported through distributor, (b)(4), that a strattice device was explanted for an unknown reason.
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Event Description
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This is a follow up #1 to report additional event and contact information provided by the surgeon through the distributor on 23/may/2018.It was reported that a 20x30cm strattice device (lot number not reported) was implanted for a hernia repair on (b)(6) 2018.Subsequently, the patient had wound and fascia dehiscence with evisceration of bowels.The strattice device was explanted on (b)(6) 2018 and could not be "reused" due to tearing.Currently the patient is stable, but still hospitalized.As reported in the initial: limited information was reported through distributor, gdm, that a strattice device was explanted for an unknown reason.
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Manufacturer Narrative
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Although it was reported that the patient had wound and fascia dehiscence and that there was device tearing, based upon the visual inspection of the returned device, no evidence of dehiscence/device tearing was observed.As previously reported, the bottom left hand corner of the device appeared to have been surgically cut.It cannot be confirmed if the device tore in that location.It should also be noted that while the customer reported that a 20x30cm piece of strattice was used, the device measured at 20x25cm during visual inspection.The lot number associated with this event was not reported and remains unknown; therefore an internal investigation into the device history records could not be performed.Based on a visual inspection of the device alone, a nonconformance could not be confirmed.It should be noted that patient factors such as extreme obesity could have contributed to the wound and fascia dehiscence.As per the ifu, potential adverse events are those typically associated with surgical mesh materials and/or their implantation procedures including, but not limited to, wound dehiscence.As reported in the initial: results: the explanted device was returned to lifecell for evaluation in formalin solution.Based upon a visual inspection, the device was observed to have scattered brown and yellow material on the surface, which appears to be biological in nature.Six sutures were present and intact on the upper portion of the device and the bottom left hand corner appeared to have been surgically cut.No other defects or irregularities were observed.The device was fully intact with no signs of degradation.The lot number remains unknown; therefore a review of the device history records could not be performed.Conclusion: multiple attempts have been made by the distributor to gather additional information from the surgeon about the nature of the complaint, lot number, and dates.At this time, no further information has been provided.This event is being reported in caution based on the report from the distributor that the device was explanted.Based on a visual inspection of the device alone, a nonconformance was not confirmed.If additional information is received, a follow up report will be submitted.No further actions are required at this time.
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Search Alerts/Recalls
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