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

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.

• Brand Name: MESH TSL - PERMACOL¿
• Type of Device: MESH, 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 Key: 8060220
• MDR Text Key: 126905751
• Report Number: 9615742-2018-02540
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNK-PERMACOL
• Device Catalogue Number: UNK-PERMACOL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/17/2018
• Initial Date FDA Received: 11/12/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 37 YR