It was reported through a legal event that a male patient had hernia repair surgery on or about (b)(6) 2014.During the hernia repair surgery, the surgeon implanted a strattice mesh product; model number: 0616002.After surgery, the patient returned to the hospital on or about (b)(6) 2017 and underwent a mesh revision operation.No other information was provided.
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This legal event is being reported as serious injury due to the reported recurrence with surgical intervention.The lot associated with this event was not reported and remains unknown; therefore an internal investigation into the device history records could not be performed.No strattice devices were returned for evaluation.Based on the limited information, including no identification of the lot number, and without relevant patient factors, a relationship between the event and the strattice could not be determined.Due to the legal process, if additional information is made available during legal proceedings, a supplemental report will be submitted.
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