MAUDE Adverse Event Report: ETHICON INC. ULTRAPRO MESH UNKNOWN PRODUCT; MESH, SURGICAL, POLYMERIC

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ecchymosis (1818); Hematoma (1884); Unspecified Infection (1930); Pain (1994); Seroma (2069); Urinary Retention (2119); Hematuria (2558); Fluid Discharge (2686); Thrombosis/Thrombus (4440); Swelling/ Edema (4577)

Event Date 05/20/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.(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: journal of robotic surgery: https://doi.Org/10.1007/s11701-021-01251-2.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a 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 (prolene polypropylene mesh, ultrapro mesh) involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with the ethicon products involved? patient demographics? event related to prolene mesh device reported via mw # 2210968-2022-01183.

Event Description

It was reported in a journal article with title: robotic abdominal wall repair: adoption and early outcomes in a large academic medical center.This retrospective observational study aims to describe the initial experience of 312 patients undergoing robotic hernia repair at a large, multi-center academic hospital.From july 1, 2016 to march 18, 2020, all patients undergoing robotic-assisted abdominal wall repair (rawr) at a single academic institution were reviewed.A total of 312 patients undergoing robotic hernia repair were identified and included in this study.The mean age among the cohort was 54 years (sd 16).69% of patients were male, 31% were female.Of the 312 rawrs, 174 were inguinal hernia repairs and 13 were abdominal wall hernia repairs.All inguinal hernia repairs were done via the trans-abdominal preperitoneal (tapp) approach.Nearly all inguinal hernias (172) were repaired using synthetic permanent mesh while only two were repaired using synthetic absorbable mesh.By far, mesh placement in the extraperitoneal location was the most common with 26% of the entire cohort using this type of repair.The remainder of the ventral hernias were repaired with a variety of mesh location (preperitoneal, retro-muscular, or onlay) with or without component separation or transversus abdominis release (tar).Mesh used included prolene® (ethicon) and ultrapro advanced¿ (ethicon) in extraperitoneal ventral hernia repairs and prolene® used in intraperitoneal onlay mesh (ipom) technique.Reported complication included: there were (55 minor post-operative events (clavien¿dindo grade i (n=53) ¿ii (n=3 ) and 5 major post-operative (clavien¿dindo grade iii (n=3)¿iv (n=2)) events.Clavien¿dindo grade ii requires medical treatment; grade iii requires procedural intervention, grade iv requires treatment in the intensive care unit.59 patients had at least one complication at 30-days.These include seroma (n=52), hematoma (n=4) , surgical-site infections (n=2) and deep venous thrombus (dvt) (n=1), these were all treated with supportive care and observation without additional morbidity.For infected hematoma required drainage by interventional radiology and a course of oral antibiotics.A second hematoma was drained in the outpatient clinic with no further morbidity.All seromas were treated with supportive treatment and observation.Presentation to the emergency department (ed) within 30-days: bruising (n=?) , swelling (n=?), discharge (n=?) ,uncontrolled post-operative , pain (n=10), urinary retention or hematuria (n=3).Of all the patients who presented to the ed, only 6 required readmissions; 2 for pain control, 2 for wound infection.Small bowel serosal tears (n=14).It was concluded, that the adoption of robotic-assisted hernia repair is increasing, both among newly trained surgeons and established surgeons.Our initial experience of 312 patients demonstrates favorable results with comparable short-term outcomes for a wide variety of hernia repairs using the robotics platform, even in the initial stages of adoption.Further studies focusing on long-term outcomes, costs, and patient satisfaction are needed.

• Brand Name: ULTRAPRO MESH UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-GMBH; robert-koch strasse 1; p.o. box 1409; norderstedt D2284 1; GM D22841
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13563477
• MDR Text Key: 289317013
• Report Number: 2210968-2022-01184
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention