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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACELL, INC. GENTRIX SURGICAL MARIX, THICK 30 UNK MESH, SURGICAL

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ACELL, INC. GENTRIX SURGICAL MARIX, THICK 30 UNK MESH, SURGICAL Back to Search Results
Catalog Number PSMT3040
Device Problem Contamination (1120)
Patient Problems Purulent Discharge (1812); Necrosis (1971)
Event Date 09/07/2018
Event Type  Injury  
Event Description
The pt underwent a reduction of a large ventral hernia and transverse abdominal muscle release with retrorectus placement of biological mesh (gentrix) for large ventral hernia repair on (b)(6) 2018. On (b)(6) 2018, the pt was returned to surgery due to foul smelling drainage from the surgical site. Intraoperatively, she was found to have necrotizing soft tissue infection involving the posterior sheath and transverse abdominal muscle, the peritoneum and the contaminated mesh. The mesh was removed. The pt's cultures grew enterococcus avium. The pt remains in critical condition requiring repeat abdominal irrigation and debridements and wound vac in place. Dates of use: (b)(6) 2018 - (b)(6) 2018. Diagnosis or reason for use: hernia repair. Gentrix.
 
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Brand NameGENTRIX SURGICAL MARIX, THICK 30 UNK
Type of DeviceMESH, SURGICAL
Manufacturer (Section D)
ACELL, INC.
MDR Report Key7897615
MDR Text Key121561801
Report NumberMW5080030
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 09/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/20/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2020
Device Catalogue NumberPSMT3040
Device Lot Number013345
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 09/20/2018 Patient Sequence Number: 1
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