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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); Fistula (1862); No Code Available (3191)
Event Date 01/01/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). Title permacol collagen paste injection for treatment of complex cryptoglandular anal fistulas: an observational cohort study with a 2-year follow-up. Source surgical innovation 2019, vol. 26(2) 168¿179. If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the literature, this study aimed to evaluate long-term clinical outcomes of treatment with mesh collagen paste for complex cryptoglandular anal fistulas. A total of 46 patients underwent paste injection. At the 1-month follow-up, 2 patients had paste extrusion, and 2 had anal abscesses. It was reported 19 patients experienced a recurrent fistula after failed 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 Key8605285
MDR Text Key144873061
Report Number9615742-2019-01684
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation
Type of Report Initial
Report Date 05/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/13/2019
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 Received04/22/2019
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: 05/13/2019 Patient Sequence Number: 1
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