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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 Migration or Expulsion of Device (1395)
Patient Problems Abscess (1690); Cellulitis (1768); Necrosis (1971)
Event Date 02/25/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4). Title a retrospective, italian multicenter study of complex abdominal wall defect repair with a permacol biological mesh source scientific reports, volume 10, 2020(1-8) date of publication: 25feb 2020. If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the literature case study about the efficacy of a cross-linked, acellular porcine dermal collagen matrix implant mesh for complex abdominal wall defect (cawd) repair between january 2010 and may 2016 which included 60 patients, the following outcomes were reported: 21 surgical site occurrence (sso) at 30 postoperative days; and (2) recurrence rate at 1-year and 2-years follow-up. Surgical site occurrence was defined the presence of one or more of the following features: 14 wound dehiscence, 1 skin/fat necrosis, 1 cellulitis/abscess, hematoma, 5 seroma and/or enterocutaneous fistula. One patient with minor wound dehiscence had the mesh removed after transcutaneous migration of the implant. It was reported that this patient¿s body did not incorporate the mesh, but rather created a thick fibrotic layer without a hernia defect; the mesh was rejected a little at time, until the surgeon decided to remove it.
 
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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 Key9914633
MDR Text Key191409416
Report Number9615742-2020-00766
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,literature
Reporter Occupation
Type of Report Initial
Report Date 04/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/02/2020
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 Received03/17/2020
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: 04/02/2020 Patient Sequence Number: 1
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