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U.S. Department of Health and Human Services

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

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SOFRADIM PRODUCTION SAS UNKNOWN PARIETEX MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number UNKNOWN PARIETEX
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Necrosis (1971); Pain (1994); Seroma (2069); Post Operative Wound Infection (2446); No Code Available (3191)
Event Date 06/07/2018
Event Type  Injury  
Manufacturer Narrative

Title laparoscopic versus hybrid approach for treatment of incisional ventral hernia: a prospective randomized multicenter study of 1-month follow-up results source hernia, volume 22, 2018 (1015¿1022) date of publication: 7 june 2018. If information is provided in the future, a supplemental report will be issued.

 
Event Description

According to literature source of study perfomed november 2012 to may 2015,193 patients undergoing laparoscopic incisional ventral hernia for primary incisional hernia with fascial defect size from 2 to 7 cm were recruited in 11 finnish hospitals. Patients were randomized to either a laparoscopic (lg) or to a hybrid (hg) repair group. The outcome measures were the incidence of clinically and radiologically detected seromas and their extent 1 month after surgery, peri/postoperative complications, and pain. There were 15 (16%) patients in lg and 11 (12. 2%) patients in hg who had postoperative complications. 13 patients in lg were readmitted to the hospital due to pain within 30 days of follow-up¿nine of them had seroma and two with pain in the area of transabdominal suture, and the reason for pain in other two remained unexplained. There were five reoperations reported during the 30-day postoperative period. In lg, one patient had a reoperation due to pain and a high c-reactive protein (crp) level. A part of the omentum was necrotic and, therefore, resected. This patient recovered well and was discharged on the sixth postoperative day. The other four were in the hg group. In hg, one patient suffered from an intra-abdominal infection and underwent a laparotomy with mesh removal. Another patient had a wound infection, which was treated with vacuum- assisted therapy, and finally, the wound was covered with a skin graft. One patient suffered from intensive pain in the area of the lateral transabdominal suture. In a reoperation, this suture was found to be entangled with a subcutaneous nerve and was removed. The pain was relieved afterwards. In this study, there were six bowel injuries, from which one in hg remained undetected. Regardless of the reoperation on the third postoperative day and the open abdomen treatment in the intensive care unit, this event led to multi-organ failure and finally to the death of this patient. In the one-month follow-up seromas were clinically detected in 73 (39. 7%) and radiologically in 102 (55. 4%) of the 180 patients. The seromas in lg were significantly larger, and six of these patients needed seroma puncture. According to the morales¿conde classification, only half of these postoperative seromas¿31 (49. 2%) in lg and 19 (48. 7%) in hg¿are graded as complications. Death was not related to the device but trocar insertion injuring the bowel. Laparoscopic versus hybrid approach for treatment of incisional ventral hernia: a prospective randomized multicenter study of 1-month follow-up results m. Ahonen-siirtola published online: 7 june 2018.

 
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Brand NameUNKNOWN PARIETEX
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 Key8255421
MDR Text Key133315708
Report Number9615742-2019-00142
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeFI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,LITERATURE
Reporter Occupation
Type of Report Initial
Report Date 01/16/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/16/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberUNKNOWN PARIETEX
Device Catalogue NumberUNKNOWN PARIETEX
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/19/2018
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: 01/16/2019 Patient Sequence Number: 1
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