Currently, it is unknown to what extent the device may have caused or contributed to the reported event.
Based on the information provided, the patient experienced adhesions, adhesions is a known inherent risk of surgery and is identified in the adverse reaction section of the instructions-for-use as a possible complication.
Based on the information provided, there is an error with the dates provided in the sequence of events.
If additional event and/or evaluation information is obtained, a follow up mdr will be submitted.
Not returned to manufacturer.
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