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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 UNK-PERMACOL
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Fever (1858); Fistula (1862); Hematoma (1884); Incontinence (1928); No Code Available (3191)
Event Date 08/26/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, 21 patients were treated with paste injection for treatment of complex cryptoglandular anal fistulas. The approach consisted of loose seton positioning followed several weeks later by closure internal opening with a resorbable sutures associated with paste injection into the fistula track. Clinical outcomes were assessed in terms of healing rate, fecal continence and patient satisfaction. Seton drainage was done in all patients in both groups for a median duration of 8 weeks (range 4¿18 weeks) before the final surgery. Post-operatively, one patient had operative failure which required a second surgery due to post surgical perianal abscess, two patients required hospitalization within a week of surgery due to fever >38. 5 celsius, one patient had a perianal hematoma, 9 patients experienced fistula recurrence and which required further intervention, 3 patients experienced anal abscesses at the paste injection site and one patient had fecal incontinence that they did not have pre-paste injection. Article: comparison of porcine collagen paste injection and rectal advancement flap for the treatment of complex cryptoglandular anal fistulas: a 2-year follow-up study author: michele schiano di visconte, gabriele bellio year: 26 august 2018 publication: # springer-verlag gmbh germany, part of springer nature 2018.
 
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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 Key8060220
MDR Text Key126905751
Report Number9615742-2018-02540
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 foreign,health professional,l
Reporter Occupation
Type of Report Initial
Report Date 11/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNK-PERMACOL
Device Catalogue NumberUNK-PERMACOL
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 Received10/17/2018
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: 11/12/2018 Patient Sequence Number: 1
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