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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 Unspecified Infection (1930); Seroma (2069); Hernia (2240); Post Operative Wound Infection (2446); Not Applicable (3189); No Code Available (3191)
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: iosr journal of dental and medical sciences (iosr-jdms). 2013; 10(6): pp 08-10. (b)(4).

 
Event Description

It was reported via journal article: "title: outcomes of laparoscopic ventral hernia repair as compared to open repair, in a tertiary care government hospital in north india. " author: dr gaurav goyal, dr ashok kumar mathur, dr. Shalu gupta, dr. Neetu aggarwal citation: iosr journal of dental and medical sciences (iosr-jdms). 2013; 10(6): pp 08-10. The authors undertook a prospective non-randomized study of ventral hernia cases from 1st october 2010 to 30th september 2011, at sawai man singh hospital, a tertiary care government hospital in north india. A total of 30 cases were done (13male and 17 female patients), 15 by laparoscopic and 15 by open repair. The laparoscopic ventral hernia repair was done using 10 mm 0 and 30 degree telescopes. Either prolene polypropylene mesh (ethicon) or proceed dual mesh (ethicon) of appropriate size, giving atleast 3 cm overlap to the hernia defect, was used depending on the affordability of the patient. In all patients, the mesh was placed intraperitoneally. In all cases, the mesh was fixed to the full thickness of the abdominal wall using transabdominal prolene 2-0 sutures (ethicon), placed at fixed intervals along the margin of the defect. In the open mesh repair of ventral hernia, the prolene polypropylene mesh (ethicon) was then placed correspondingly in an onlay fashion with atleast 3 cms overlap over the defect and fixed using prolene 2-0 sutures (ethicon). Suction drains used in all cases. In the laparoscopic ventral hernia repair group, reported complications included paralytic ileus (n-4) and seroma (n-10). In the open mesh repair of ventral hernia, reported complications included paralytic ileus (n-5), seroma (n-3), wound infection (n-6), mesh infection (n-2) which required subsequent mesh removal, and hernia recurrence (n-3). Laparoscopic repair of ventral hernia is a safe and effective technique with lesser post-operative pain, shorter hospital stay and no wound infections. Seroma formation is very common but it doesn¿t adversely affect outcomes. Our study found no mesh infection and no recurrence of hernia at 6 months follow up in the laparoscopic group. Hence, laparoscopic repair should be preferred method of treatment of ventral hernias.

 
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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 Key8887786
MDR Text Key154124979
Report Number2210968-2019-85467
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeIN
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,Followup
Report Date 07/15/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/13/2019
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? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/15/2019
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: 08/13/2019 Patient Sequence Number: 1
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