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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); Hernia (2240); 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: kasr el aini journal of surgery 2010; 11:75-86. (b)(4).

 
Event Description

It was reported via a journal article"title : the combined use of polypropylene and polyglactin meshes for a two layered immediate repair of large abdominal wall defects following tumor resection". Author : mohamed a f el zohairy *, mohammed a rifaat*, ehab m el husseiny. Citation: kasr el aini journal of surgery 2010; 11:75-86. The aim of this study is to report on the outcome of the use of the double layered mesh technique in reconstructing large full thickness abdominal wall defects following tumor resection in our institution. From january 2006 to december 2009, a total of 28 patients (n=6 males and n=22 females, age range: 25-73 years, mean age: 36. 8 years) presenting with abdominal wall tumors underwent resection and immediate reconstruction of the abdominal wall defects. Closure of the fascial defect was done in two layers (double layered technique). The posterior deep fascial layer was reconstructed using absorbable polyglactin (vicryl) mesh (ethicon) sutured in a tension-free manner to the edges of the fascial defect by running 2-0 vicryl sutures (ethicon). The anterior fascial layer was reconstructed by nonabsorbable polypropylene (prolene) mesh (ethicon). The mesh should be overlapping the edges of the fascial defect by 2-3 cm and sutured in a tension-free manner using interrupted 0 prolene sutures (ethicon). Complaint included wound infection (n=2), seroma (n=4), wound dehiscence (n=4), and hernia (n=1) developed 12 months after surgery in a patient who had initially presented with a desmoid tumor. Infections were treated conservatively, and dehisced wounds healed spontaneously with local wound care. Three seromas responded well to repeated aspirations and only one seroma persisted for 5 months despite repeated aspirations and formed a pseudo bursa. The latter was treated surgically by curettage of the bursa followed by complete recovery. The patient with hernia refused further surgical intervention and preferred to use an abdominal binder. In conclusion, the abdominal wall defects following tumor resection in which major exposure of the viscera is present, double layered closure with vicryl and prolene meshes is simple, safe, easy and a less expensive way of achieving sound abdominal wall closure with minimal complications once adequate skin coverage is provided.

 
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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
Manufacturer (Section G)
ETHICON INC.
Manufacturer Contact
kara ditty-bovard
p.o. box 151, route 22 west
somerville, NJ 08876
6107428552
MDR Report Key9547582
MDR Text Key185904814
Report Number2210968-2020-00066
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 12/11/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/03/2020
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 Received12/11/2019
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: 01/03/2020 Patient Sequence Number: 1
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