(b)(4).To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.Attempts are being made to obtain the additional information.To date no response has been provided.If further details are received at the later date a supplemental medwatch will be sent.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Does the surgeon believe that ethicon products involved caused and/or contributed to the adverse events described in the article? if yes, provide details of event and specific suture product code.Can specific patient demographics be provided for each of the subjects of this article? if yes, please include: date and type of procedure, where procedure was performed, specific medical/surgical intervention per patient, product involved, pre-existing conditions.Are the product code and lot numbers available for ethicon devices used?.
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It was reported in a journal article that the patient underwent an inguinal hernia repair procedure on unknown date and the mesh was implanted using the lichtenstein technique.It was possible that the patient experienced either wound infection postoperatively, pain of any severity at 12 months, testicular pain, recurrence, contralateral hernia and/or testicular atrophy.Additional information has been requested.
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