|
Model Number UNKNOWN PARIETEX PRODUCT |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Arrhythmia (1721); Hematoma (1884); Pain (1994); Urinary Retention (2119); Prolapse (2475); No Code Available (3191)
|
Event Date 09/28/2014 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).Title laparoscopic spigelian hernia repair: a series of 40 patients source surg laparosc endosc percutan tech, volume 25, 2015 (e86¿e89) article number: 3 date of publication: september 28, 2014.If information is provided in the future, a supplemental report will be issued.(b)(4).
|
|
Event Description
|
According to the literature source of study performed, on patient's with spilegian hernia, a composite mesh was used to repair the defect, and was secured into positioned using tackers.All 40 patients were symptomatic with intermittent flank pain being the most common complaint.There were postoperative complications reported in 4 patients (10%) including bleeding (1 hematoma managed conservatively in the extraperitoneal group), urinary retention (1 patient in the extraperitoneal group), arrhythmia (1 postoperative atrial fibrillation with rate control using digoxin in the intraperitoneal group), and ileus (1 patient in the intraperitoneal group had a 5-day hospital stay on intravenous antibiotics; there was no obstruction or bleeding on computed tomography (ct) imaging).There were no mortalities.One patient (2.5%) had a recurrence following an intraperitoneal approach and has undergone a successful open repair with an on-lay mesh (an extraperitoneal approach was not possible due to previous inguinal hernia mesh placement).
|
|
Search Alerts/Recalls
|
|
|