• 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 POLYPROPYLENE MESH UNKNOWN PRODUCT 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 POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Post Operative Wound Infection (2446)
Event Type  Injury  
Manufacturer Narrative

(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. Citation: journal of the college of physicians and surgeons pakistan. 2009; vol. 19 (12): 763-767. (b)(4).

 
Event Description

It was reported via journal article: "title: open extraperitoneal mesh repair for abdominal wall hernias in females" author/s: badar murtaza, naser ali khan and imran bashir malik* citation: journal of the college of physicians and surgeons pakistan. 2009; vol. 19 (12): 763-767. The objectives of this quasi-experimental study was to determine the outcome of treatment in terms of infection and recurrence using open extraperitoneal mesh repair technique. A total of 32 cases (all female patients; mean age: 41. 25 ± 10. 79 years) with abdominal wall hernias with defect of 4 cm or more were studied. During the surgical procedure, once adequate extraperitoneal space had been created, this layer was closed in the midline by continuous vicryl 2-0 sutures (ethicon). It was then washed with normal saline and redivac suction drain(s) was placed over the prolene mesh (ethicon). In all the cases, polypropylene mesh was placed over this layer and secured with interrupted vicryl 2-0 sutures (ethicon). The superficial layers were then closed accordingly with vicryl 2-0 (ethicon) in the subcutaneous fat and prolene 3-0 (ethicon) over the skin. Reported complication included one morbidly obese patient with superficial wound infection and was treat with intravenous antibiotics. In this study, extraperitoneal mesh repair was found to be a successful proceeding in the abdominal wall hernias in females. Abdominal wall hernia are common in female patients with a history of previous surgical intervention. Open extraperitoneal mesh repair with placement of redivac drains is an effective method for the management of abdominal wall hernias with a low complication rate and low recurrence even in large hernial defects.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
Manufacturer (Section G)
ETHICON INC.-SAN LORENZO PR
road 183, km. 8.3
san lorenzo 00754
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key8913490
MDR Text Key155043433
Report Number2210968-2019-85879
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodePK
PMA/PMN NumberK962530
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,LITERATURE
Reporter Occupation
Type of Report Initial
Report Date 07/26/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/20/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/26/2019
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: 08/20/2019 Patient Sequence Number: 1
-
-