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U.S. Department of Health and Human Services

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

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SOFRADIM PRODUCTION SAS UNKNOWN PROGRIP MESH PRODUCT MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number UNKNOWN PROGRIP MESH PRODUCT
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Wound Dehiscence (1154); Hematoma (1884); Pain (1994); Seroma (2069)
Event Date 05/08/2020
Event Type  Injury  
Manufacturer Narrative

Title: updates in surgery: is the sublay self-gripping mesh effective for incisional ventral hernia repair? our experience and a systematic review of the literature source: received: 31 january 2020 / accepted: 7 april 2020 https://doi. Org/10. 1007/s13304-020-00762-1, the author(s) 2020. If information is provided in the future, a supplemental report will be issued.

 
Event Description

According to literature source of study performed june 2016 to november 2018, the aim of this study was to report our experience with retromuscular repair and self-gripping mesh for the treatment of midline incisional hernias. The mesh was used to treat incisional hernias. Early postoperative complications were seroma occurred in two patients and was treated with fluid aspiration; two hematoma and two wound dehiscence also occurred and were treated conservatively. Late postoperative complications were recurrence (three) and two patients suffered from occasional mild pain.

 
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Brand NameUNKNOWN PROGRIP MESH 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 Key10291078
MDR Text Key199329393
Report Number9615742-2020-01647
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeIT
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 07/17/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/17/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberUNKNOWN PROGRIP MESH PRODUCT
Device Catalogue NumberUNKNOWN PROGRIP MESH 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 Received06/30/2020
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: 07/17/2020 Patient Sequence Number: 1
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