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

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.

• Brand Name: UNKNOWN PARIETEX PRODUCT
• Type of Device: MESH, 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 Key: 8733237
• MDR Text Key: 149154133
• Report Number: 9615742-2019-02294
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN PARIETEX PRODUCT
• Device Catalogue Number: UNKNOWN PARIETEX PRODUCT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/04/2019
• Initial Date FDA Received: 06/26/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other