MAUDE Adverse Event Report: ETHICON INC. PROLENE HERNIA SYSTEM; MESH, SURGICAL, POLYMERIC

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

Patient Problems Seroma (2069); Urinary Retention (2119); Post Operative Wound Infection (2446); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The single complaint was reported with multiple events through a journal article.No specific patient information regarding events has been provided and it is unknown if the events have been previously reported.The manufacturing record evaluation cannot be reviewed as the lot number has not been provided.Author: sudhir kumar jain ms frcs , m jayant mbbs ms, c norbu mbbs citation: tropical doctor.2008; 38: 80¿82.Doi: 10.1258/td.2007.060031.

Event Description

It was reported in a journal article entitled: the role of antibiotic prophylaxis in mesh repair of primary inguinal hernias using prolene hernia system: a randomized prospective double-blind control trial.Antibiotic prophylaxis is being commonly used in mesh repair of inguinal hernia but its role has been questioned in a recent cochrane analysis performed in 2003.In a present double-blind placebo controlled trial involving 120 patients (60 patients ¿ antibiotic group; mean age: 41.28 ± 11.49; all male patients; 60 patients ¿ placebo group; mean age: 40.2 ± 9.84; all male patients) undergoing inguinal hernia repair using prolene hernia system (ethicon), the authors did not find any benefit of the routine use of antibiotic prophylaxis in terms of wound infection rate.All phs mesh repair (combination of onlay and outlay mesh) were performed by the authors.Onlay mesh was fixed with prolene 2-0 sutures (ethicon).In the antibiotic group, reported complications included urinary retention (n-1), seroma formation (n-1) which was treated conservatively by aspiration without any sequel, superficial wound infection (n-1) which required appropriate antibiotics and drainage, and post-operative hydrocele (n-1) which was treated by eversion of the sac.In the placebo group, reported complications included seroma formation (n-1) which was treated conservatively by aspiration without any sequel and superficial wound infection (n-1) which required appropriate antibiotics and drainage.It was reported that the present series seems to be the first to study the role of antibiotic prophylaxis in repairs of inguinal hernia using phs.The authors believed that this practice can be applied to any type of mesh repair in inguinal hernia but the authors do not recommend it for mesh repair of ventral hernia as that involves extensive dissection.

• Brand Name: PROLENE HERNIA SYSTEM
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): J-PAC; 25 centre rd; somersworth NH 03878
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8471855
• MDR Text Key: 140592540
• Report Number: 2210968-2019-79880
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K984220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/04/2019
• 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