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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 Wound Dehiscence (1154); Fever (1858); Seroma (2069); Post Operative Wound Infection (2446); Unspecified Tissue Injury (4559); Unintended Radiation Exposure (4565)
Event Date 01/25/2021
Event Type  Injury  
Manufacturer Narrative
Title: the use of permacol® biological mesh for complex abdominal wall repair 2021 source: minerva surgery 2021 apr 23. Doi: 10. 23736/s2724-5691. 21. 08779-4 article type: original article, 2021 edizioni minerva medica. If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the literature, a retrospective study evaluated the safety and efficacy of reported mesh in patients who underwent complex abdominal wall repair (cawr) between january 2009 and december 2018. It was noted that the mesh was placed either via inlay, sublay, or underlay. There were 75 patients included in the study, and complications included seroma. Computed tomography (ct) guided drainage was performed for collections, superficial surgical site infections managed with local treatment and antibiotics, profound surgical site infection treated with re-operation for lavage and mesh removal in one patient. Ct guided drainage in two additional patients, superficial wound dehiscence, which ultimately led to mesh removal and post-operative fever.
 
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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
tracy landers
5920 longbow drive
boulder, CO 80301
3035816943
MDR Report Key11968755
MDR Text Key255445872
Report Number9615742-2021-01439
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation
Type of Report Initial
Report Date 06/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/09/2021
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?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/17/2021
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: 06/09/2021 Patient Sequence Number: 1
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