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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 Wound Dehiscence (1154); Abscess (1690); Hematoma (1884); Seroma (2069); Hernia (2240); Post Operative Wound Infection (2446); No Code Available (3191)
Event Date 11/13/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). Title: indications and outcomes of a cross-linked porcine dermal collagen mesh (permacol) for complex abdominal wall reconstruction: a multicenter audit source world j surg, volume 43, 2019 (791-797) date of publication: 13 november 2018. If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to literature source of study performed, 250 patients underwent single-stage open abdominal wall repair (awr) for incisional hernia from 8 different university hospitals. The study reported short- and long-term outcomes after abdominal wall repair (awr) for incisional hernia using mesh. Post-operatively, in-hospital complications occurred in 154 patients. 122 patients experienced surgical site occurrence (sso) and included abscess (81 patients). Reintervention was required for 74 patients, mostly due to intraperitoneal complications (23 patients), wound abscess (27 patients) and other ssos such as seroma (8 patients), hematoma (9 patients), wound dehiscence (7 patients), and mesh explantation was required in 10 patients due to mesh disruption or migration. Long term reported outcomes include 22 patients with chronic wound infection, and 63 patients experienced hernia recurrence. The mortality and complication rates associated with the repair are high due to the patients¿ comorbidities and the degree of contamination of the operative field.
 
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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 Key8614208
MDR Text Key145214380
Report Number9615742-2019-01694
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation
Type of Report Initial
Report Date 05/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/15/2019
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: 05/15/2019 Patient Sequence Number: 1
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