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U.S. Department of Health and Human Services

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

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SOFRADIM PRODUCTION SAS SYMBOTEX MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number SYM3420E
Device Problems Failure To Adhere Or Bond (1031); Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Adhesion(s) (1695); Unspecified Infection (1930); Tissue Damage (2104); Injury (2348); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

The attorney alleged a deficiency against the device resulting in an unspecified adverse outcome. Product was used for therapeutic treatment. Preoperative and postoperative diagnosis was incisional hernia and umbilical hernia. The procedure performed was repair of incisional hernia with mesh, lysis of adhesions and repair of umbilical hernia with mesh. (b)(6) 2016 - approximately one-year and 3 ½ months after the (b)(6) 2014 mesh implantation. The patient underwent a surgical revision for exploratory laparotomy with extensive lysis of adhesions, incision and drainage of the abdominal wall with removal of infected prosthetic meshes, abdominal wall debridement including skin, umbilicus, subcutaneous tissue, myofascial tissue and hernia sac, and sutures, small bowel resection including meckel diverticulum and small bowel stricture with primary anastomosis, bilateral posterior rectus sheath component release, advancement and closure, hybridized with the transversus abdominis release in the subxiphoid area, for exclusion of peritoneal cavity form retromuscular space, repair of large recurrent chronically incarcerated incisional hernia with plication closure of white lateral abdominal wall defect with subsequent retromuscular placement of mesh and primary closure of autologous fascia over mesh with use of irrigations, activated autologous platelet rich plasma an drains. The pre-op diagnosis was large complex recurrent incisional hernia with symptoms of intermittent partial small -bowel obstruction; possible infected prosthetic mesh (fluid seen around mesh by ct imaging), significant risk factors and history. Active tobacco abuse with chronic obstructive pulmonary disease, history of postoperative respiratory issues. Morbid obesity with a body mass index approximately 34 kilograms per meters squared. The post-op diagnosis was infected prosthetic mesh (periumbilical dual layer or mesh with fluid and nonincorporated, but also some discolored fluid around area of larger mesh that occupies most of right greater than left upper abdominal wall). Large complex chronically incarcerated recurrent incisional hernia (large defect medial the mid upper abdominal mesh with smaller lateral defects and around infected mesh). Meckel's diverticulum with question stricture of small bowel just distal to the base of the diverticulum. Chronic obstructive pulmonary disease with active tobacco abuse and morbid obesity. The patient experienced adhesions; bowel removal, infection, mesh removal, recurrence, and revision.

 
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
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Brand NameSYMBOTEX
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 Key7332222
MDR Text Key102181764
Report Number9615742-2018-00487
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK131969
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation ATTORNEY
Type of Report Initial,Followup
Report Date 04/11/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/12/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/31/2016
Device MODEL NumberSYM3420E
Device Catalogue NumberSYM3420E
Device LOT NumberPNK0100X
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 Received02/12/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured11/16/2013
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: 03/12/2018 Patient Sequence Number: 1
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