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U.S. Department of Health and Human Services

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

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ETHICON INC. ULTRAPRO MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number ULTRAPROMUNK
Device Problems Hole In Material (1293); Appropriate Term/Code Not Available (3191)
Patient Problems Wound Dehiscence (1154); Abdominal Distention (2601); Not Applicable (3189)
Event Type  Injury  
Manufacturer Narrative

Surgical intervention, cutaneous dehiscence, omentum externalization occurred. To date the device has not been returned. If the device or further details are received at the later date a supplemental medwatch will be sent. (b)(4).

 
Event Description

It was reported in a journal article that the patient underwent an eventroplasty without closing the anterior sheet procedure on unknown date along with right-sided hemicolectomy and retroperitoneal lipoma removal and the mesh was implanted for abdominal wall reconstruction. The patient operated on to separate the bilateral posterior components. Due to the impossibility of mid-line closure, the edges of the anterior sheet were affixed to the mesh, and a bridge remained. At twenty days following the procedure, the patient experienced cutaneous dehiscence with externalization of the omentum. The patient was examined in surgery, and a central rupture in the mesh was found, which was repaired by closing the defect and using another mesh suturing it above the previous mesh at a subcutaneous position. The abdomen was initially left open and then closed in a second attempt. The patient is without symptoms and has an intact wall. The doctor opined that the distention of the abdominal wall, because intraabdominal surgery had been performed on the subsequent postoperative ileus, and the divergent tractive forces in the areas where the mesh was fixated may have caused the rupture. The doctor also opined that the mesh should be not used in obese patient, when it is unable to close the anterior myofascial layer. No further information is available.

 
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Brand NameULTRAPRO 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.-GMBH
robert-koch strasse 1
norderstedt
GM
Manufacturer Contact
jane kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key6856368
MDR Text Key85733932
Report Number2210968-2017-70247
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
PMA/PMN NumberK033337
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/16/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/11/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberULTRAPROMUNK
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 Received09/06/2019
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 09/11/2017 Patient Sequence Number: 1
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