Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.This is 16 of 17 devices being reported for the same event, as we are unable to determine which device was involved (reference 1825034-2016-03272 / 3285 and 1825034-2016-03287 / 3289).There are warnings in the package insert that state this type of event can occur: under possible adverse effects, it states, ¿infection, both deep and superficial.¿ this report is number 17 of 18 mdrs filed for the same event (reference 1825034-2016-03272 / 3289).
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