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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 Hematoma (1884); Unspecified Infection (1930); Seroma (2069); Post Operative Wound Infection (2446); No Code Available (3191)
Event Date 01/25/2020
Event Type  Injury  
Manufacturer Narrative

Title: the information has been sourced from the literature review reference: felix harpain, kerstin wimmer, christopher dawoud, philipp ogrodny, anton stift corresponding author. Währinger gürtel 18-20, 1090, vienna, austria. E-mail address: anton. Stift@meduniwien. Ac. At (a. Stift). (b)(4). If information is provided in the future, a supplemental report will be issued. (b)(4).

 
Event Description

According to literature source of study performed, this is the evaluation of short-term postoperative outcome of self-gripping versus conventional non-self-gripping meshes in sublay hernia repair. Between january 2011 and july 2018, 244 patients received a hernia repair. All 127 patients used progrip self gripping meshes with gender distribution of 61 male and 66 females, median age of 64 years old. 16 patients had surgical site infections, 30 patients had surgical site occurrences, 22 patients had seroma, 9 patients had hematoma and three patients had recurrence. In total, one or more surgical interventions of any type had to be performed in patients due to a postoperative complication. This happened significantly more often in patients receiving a self-gripping mesh. A surgical site occurrence requiring procedural interventions. This included seroma aspirations in 14 patients, the applications of a negative-pressure wound therapy in 9 patients and re-operations in 16 patients. In non self gripping meshes, 117 patients used it but only six used parietex with gender distribution of 61 male and 56 females, median age of 65 years old. Five patients had surgical site infections, 14 patients had surgical site occurrences, eight patients had seroma, six patients had hematoma and three patients had recurrence. In total, one or more surgical interventions of any type had to be performed in patients due to a postoperative complication. This happened significantly more often in patients receiving a self-gripping mesh. A surgical site occurrence requiring procedural interventions. This included seroma aspirations in 5 patients, the applications of a negative-pressure wound therapy in 5 patients and reoperations in 7 patients. Revisional surgery for postoperative complications was more often necessary in patients with self-gripping meshes than in those with non-self-gripping meshes. In patients with ventral hernia repair in sublay technique receiving a self-gripping mesh a higher rate of postoperative complications and complication associated surgical interventions were observed.

 
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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 Key9872026
MDR Text Key193292771
Report Number9615742-2020-00623
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeAU
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,LITERATURE
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/01/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/24/2020
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? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/15/2020
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: 03/24/2020 Patient Sequence Number: 1
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