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

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.

• Brand Name: PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT
• Type of Device: MESH, 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 Key: 9547582
• MDR Text Key: 185904814
• Report Number: 2210968-2020-00066
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: K962530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• 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 Received: 01/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention