The 3 of 3 reports: different patients, same event.Other mfg report numbers: 3004170064-2018-00004, 3004170064-2018-00005.It was reported an inflammatory syndrome with fever, tachycardia and high crp that lasted a few days, treated with antibiotics.The inflammation started between 0 to 7 days.It was considered a minor complication; however it doesn't convince the medical staff on the good behavior of the material and it's biocompatibility.It has nothing to do with seroma though, as they drain a lot and get rid of the redons when it's beneath 10cc/day.The patients are well after antibiotics, they have no more fever and they come back home.Surgimend was used for treatment of recurrence hernia with infection context.
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Based on the dhr review conducted, there were no anomalies found and there is no indication that the manufacturing or final packaging/labeling processes may have contributed to this complaint.Additionally, all finished goods lots released to the market by integra lifesciences meet acceptance criteria for all required inspections and tests.The failure is unconfirmed and root cause is indeterminable as there was no product returned for this complaint.
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