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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS UNKNOWN PARIETEX PRODUCT MESH, SURGICAL, POLYMERIC

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SOFRADIM PRODUCTION SAS UNKNOWN PARIETEX PRODUCT MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number UNKNOWN PARIETEX PRODUCT
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Wound Dehiscence (1154); Hemorrhage/Bleeding (1888); Seroma (2069); Hernia (2240); Post Operative Wound Infection (2446); No Code Available (3191)
Event Date 01/20/2020
Event Type  Injury  
Manufacturer Narrative

Title: further insights into the treatment of perineal hernia based on a the experience of a single tertiary centre source the authors. Colorectal disease published by john wiley & sons ltd on behalf of association of coloproctology of great britain and ireland, volume 22, 2020 (694¿702) date of online acceptance: 8 january 2020. (b)(4). If information is provided in the future, a supplemental report will be issued.

 
Event Description

According to the literature source of a study performed about the evolution of a technique for repair of perineal hernia by analyzing the experience in a tertiary referral center, synthetic mesh was used in 16 out of 34 patients. A composite mesh was used for cases of small bowel herniation in 4 out of the 16 patients and complications were noted. There were 6 patients that had perineal wound complications. 2 had dehiscence, 4 had infection, 2 had fistula, and 1 had bleeding. The perineal wounds were successfully treated with antibiotics (5) and percutaneous drainage of fluid collections (3). There were 5 recurrent perineal hernia after a median of 17 months. Of five patients with failed synthetic mesh repair, two underwent re-repair with synthetic mesh. One patient required reoperation for developing a perineal seroma after synthetic mesh placement following re-repair of a recurrence, which was excised.

 
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Brand NameUNKNOWN PARIETEX PRODUCT
Type of DeviceMESH, SURGICAL, POLYMERIC
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 Key10428960
MDR Text Key203715071
Report Number9615742-2020-01848
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeNL
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 08/19/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/19/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberUNKNOWN PARIETEX PRODUCT
Device Catalogue NumberUNKNOWN PARIETEX 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 Received08/03/2020
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: 08/19/2020 Patient Sequence Number: 1
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