• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ETHICON INC. PROLENE HERNIA SYSTEM MESH, SURGICAL, POLYMERIC Back to Search Results
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.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePROLENE HERNIA SYSTEM
Type of DeviceMESH, 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 Key8471855
MDR Text Key140592540
Report Number2210968-2019-79880
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeIN
PMA/PMN NumberK984220
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,LITERATURE
Reporter Occupation
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 Received04/01/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/04/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 04/01/2019 Patient Sequence Number: 1
-
-