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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS MESH TSL - PERMACOL¿ MESH, SURGICAL

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SOFRADIM PRODUCTION SAS MESH TSL - PERMACOL¿ MESH, SURGICAL Back to Search Results
Model Number UNKNOWN PERMACOL PRODUCT
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pulmonary Embolism (1498); Abscess (1690); Cellulitis (1768); Necrosis (1971); Hernia (2240); Obstruction/Occlusion (2422); No Code Available (3191)
Event Date 10/04/2011
Event Type  Injury  
Manufacturer Narrative
(b)(4). Title outcomes of complex abdominal herniorrhaphy. Source annals of plastic surgery. Volume 68, number 4, april 2012. Received october 2, 2011, and accepted for publication, after revision, october 4, 2011. If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the literature source study performed on 185 patients who underwent ventral hernia repair. A total of 106 patients were included. Thirty patients received synthetic meshes while 76 patients received biologic mesh. Results and complications were not reported based on mesh type so all complications were all pooled together. Sixty-seven patients developed a postoperative complication (63%). Skin necrosis was the most common complication. Other complications included seroma, cellulitis, abscess, pulmonary embolus/deep vein thrombosis, small bowel obstruction, and fistula. Thirty patients required reoperations because of postoperative complications. Seventeen patients developed recurrences.
 
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Brand NameMESH TSL - PERMACOL¿
Type of DeviceMESH, SURGICAL
Manufacturer (Section D)
SOFRADIM PRODUCTION SAS
116 avenue du formans
trevoux 01600
FR 01600
Manufacturer (Section G)
SOFRADIM PRODUCTION SAS
116 avenue du formans
trevoux 01600
FR 01600
Manufacturer Contact
lisa hernandez
60 middletown ave
north haven, CT 06473
2034925563
MDR Report Key8801031
MDR Text Key151415211
Report Number9615742-2019-02587
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 Manufacturer
Source Type health professional,literatur
Reporter Occupation
Type of Report Initial
Report Date 07/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/17/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNKNOWN PERMACOL PRODUCT
Device Catalogue NumberUNKNOWN PERMACOL PRODUCT
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/01/2019
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: 07/17/2019 Patient Sequence Number: 1
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