Product complaint # (b)(4).This report is related to a journal article; therefore, no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided. the single complaint was reported with multiple events.There are no additional details regarding the additional events. citation: infect inflamm rep, vol.12, no.3, september 2011. event related to the prolene 3d patch mesh reported via mw # 2210968-2021-03475.
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It was reported in a journal article with title: experience of the use of prolene 3d patch and prolene hernia system in the repair of inguinal hernia: report of 106 cases.The objective of this study is to observe the effects of prolene 3d patch (3dp) and prolene hernia system (phs) in the repair of inguinal hernia.From january to august 2009, 106 patients with inguinal hernia that were repaired with 2 types of patches were included in the study.There were 98 males and 8 females with a mean age of 59.4 +/- 13.7 years (range 25 to 81 years).There were 98 cases of unilateral hernia, including 97 cases of primary hernia and 1 case of recurrent hernia.There were eight cases of bilateral hernia.There were 12 cases concomitant with chronic respiratory diseases, 4 cases with prostatic hypertrophy, 2 cases with hypertension, 4 cases with diabetes mellitus, and 4 cases with long-term constipation.For the 57 cases with small-diameter hernia ring and no obvious defect of transverse abdominal fascia, the prolene 3d patch (ethicon) was used; for the 49 patients with large-diameter hernia ring, weak or obvious defect of transverse abdominal fascia, and no serious contamination of the operative area, prolene hernia system (ethicon) was used.There were no complications of the heart, brain, and lung after the operation.The postoperative follow-up was 18 to 26 months, with an average of 20 months, with no recurrence.Postoperative complications include acute urinary retention (n=2), and after indwelling the catheter, spontaneous urination was restored 1 to 2 days later.
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