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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 Pneumonia (2011); Urinary Tract Infection (2120); Hernia (2240); Obstruction/Occlusion (2422); Post Operative Wound Infection (2446); No Code Available (3191)
Event Date 03/01/2009
Event Type  Injury  
Manufacturer Narrative

(b)(4). (2 patients had debridement of the subcutaneous tissue, and eventual vacuum-assisted closure of the wound) title: the midwest surgical association polyester-based mesh for ventral hernia repair: is it safe? source: michael j. Rosen, m. D. * the american journal of surgery (2009) 197, 353¿359. If information is provided in the future, a supplemental report will be issued. (b)(4).

 
Event Description

According to the literature, 109 patients underwent ventral hernia repair on the same facility. 79 patients had undergone laparoscopic surgery where they underwent intraperitoneal placement of polyester based mesh with a collagen hydrogel anti adhesive barrier. The mesh was sized for at least 4 cm of fascial overlap, and transfascial fixation sutures and titanium spiral tacks were used routinely to secure the mesh to the abdominal wall. 30 patients underwent open ventral hernia repair, performed using a retrorectus repair, placing the mesh in an extraperitoneal position. Unprotected polyester mesh was used in these cases. The patients are placed in an abdominal binder for 6 weeks. Postoperative complications occurred in 8 (27%) patients and included superficial wound infection, deep wound infection with exposure of mesh, ileus, pneumonia, and urinary tract infection. The 2 patients with exposed mesh underwent debridement of the subcutaneous tissue, and eventual vacuum-assisted closure of the wounds with complete salvage of one of the meshes, and only partial resection of the other with eventual complete wound healing. With the follow-up period of around 11 months there have been 3 (10%) recurrent hernias. Two of these recurrences occurred in very large defects (350 cm2 and 459 cm2), and 1 occurred after a skin breakdown, with exposed mesh requiring local excision of the central aspect of the mesh and eventual recurrence at that site. It was noted that in the laparoscopic procedure there were 41% which had recurrent hernias while in open surgery there were 47% of recurrent hernias.

 
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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 Key8733237
MDR Text Key149154133
Report Number9615742-2019-02294
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,LITERATUR
Reporter Occupation
Type of Report Initial
Report Date 06/25/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/26/2019
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 Received06/04/2019
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: 06/26/2019 Patient Sequence Number: 1
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