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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 Abscess (1690); No Code Available (3191)
Event Date 01/01/2018
Event Type  Injury  
Manufacturer Narrative
Title of article: permacol collagen paste injection for treatment of complex cryptoglandular anal fistulas: an observational cohort study with a 2-year follow-up authors: michele schiano di visconte, md1 , andrea braini, md2, luana moras, md3, luigi brusciano, md, phd4 , ludovico docimo, md, phd4, and gabriele bellio, md1 year published: 2018. (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the literature case, the study was performed to evaluate the long-term clinical outcomes of treatment with collagen paste for complex cryptoglandular fistulas. The study included a total of 46 patients that underwent collagen paste injection. At one-month follow-up two patients had paste extrusion and two patients had anal abscesses. A total of 19 patients had recurrent fistula after failed collagen paste injection and required additional operative procedures.
 
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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 Key8445985
MDR Text Key139666995
Report Number9615742-2019-00631
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeIT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 03/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/22/2019
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 Received02/27/2019
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: 03/22/2019 Patient Sequence Number: 1
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