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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC

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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 Problems Seroma (2069); 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. 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 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 used in this procedure? citation: surg today. 2015; 45: 429¿433. Doi: 10. 1007/s00595-014-0907-3. (b)(4).

 
Event Description

It was reported via journal article: title: "prospective randomized evaluation of open preperitoneal versus preaponeurotic primary elective mesh repair for paraumbilical hernias," authors: mohammad hamdy abo-ryia, osama helmy el-khadrawy, gamal ibrahim moussa, ahmad mohammad saleh. Citation: surg today. 2015; 45: 429¿433. Doi: 10. 1007/s00595-014-0907-3. The aim of this study was to compare the preperitoneal versus the preaponeurotic mesh positioning in open paraumbilical hernia repair. During the period from january 2011 until july 2012, 60 adult patients (49 female and 11 male patients) were randomly assigned to 2 equal groups. The patients in group a (n-30; mean age: 46. 80 ± 12. 12; bmi: 29. 74 ± 3. 23) were treated by pre-peritoneal mesh repair and those in group b (n-30; mean age: 48. 33 ± 12. 34; bmi: 29. 90 ± 3. 18) underwent pre-aponeurotic mesh repair. During the surgical procedure in group a, prolene mesh (ethicon) was inserted and spread in the space that was created, and the defect was closed by prolene 0 sutures (ethicon), taking bites through the mesh center to avoid its dislocation. The umbilicus was repositioned by vicryl 2-0 sutures (ethicon). The subcutaneous tissue was closed by interrupted vicryl 2-0 sutures (ethicon), and the skin was closed with subcutaneous prolene 3-0 sutures (ethicon). During the surgical procedure in group b, after the dissection and reduction of the hernia, the defect was closed by prolene 0 sutures (ethicon), and the subcutaneous tissue was dissected to expose the aponeurosis for 5¿6 cm all around the edge of the defect, then the prolene mesh (ethicon) was fixed by prolene 2-0 sutures (ethicon) both circumferentially and centrally. A closed suction drain was then inserted, and the umbilicus was repositioned using vicryl 2-0 sutures (ethicon). In group a, reported complications included superficial wound infection (n-2) and hematoma (n-2). In group b, reported complications included superficial wound infection (n-3), hematoma (n-2), and seroma formation (n-5). The preperitoneal mesh placement during the repair of paraumbilical hernias is superior to the preaponeurotic placement, because it is associated with fewer complications, less pain, and a shorter time of return to normal daily activities.

 
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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 Key7926346
MDR Text Key122341513
Report Number2210968-2018-76208
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeEG
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 09/04/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/02/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
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 Received09/04/2018
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: 10/02/2018 Patient Sequence Number: 1
Treatment
VICRYL SUTURE, PROLENE SUTURE
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