(b)(4).Review of lot processing history and complaint history records for lot sp100409 was unremarkable.There were no processing deviations or nonconformance related to the nature of this complaint and the lot met qc criteria for release, including mechanical testing results.As of 02/20/2017, no other complaints were reported to lifecell against lot sp100409.As of 02/20/2017, of the (b)(4) devices released to finished goods for lot sp100409, (b)(4) devices were distributed with 60 devices reported to be implanted.Evaluation conclusion: (b)(4).The event is unlikely related to strattice and likely due to the patient's condition including coughing, concurrent panniculectomy, and high bmi.Based on our internal review of the device processing history, the lot met qc criteria for product release.No deviations were encountered in association with the event.No other complaints were reported to lifecell against the lot.Device not returned for evaluation.
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It was reported to lifecell that a patient underwent concurrent panniculectomy and ventral hernia repair on (b)(6) 2017.The surgeon utilized a strattice mesh as an onlay bridge sutured to the rectus muscle to repair a large defect that was 20 cm in vertical length and 15 cm across.On (b)(6) 2017, the patient coughed and heard a "pop".The patient was returned to the or where it was found that the strattice mesh had split through the middle.The surgeon removed the strattice and stated that at the time of explant, the mesh was "mushy" to the touch.No pre-operative or post-operative infection was seen and no culture testing information is available.The strattice was replaced, the wound was left open, and wound vac therapy was applied.Two drains in lateral flanks were placed during surgery.No seroma was found.
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