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

Model Number SYM12

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pulmonary Embolism (1498); Diarrhea (1811); Fever (1858); Unspecified Infection (1930); Inflammation (1932); Nausea (1970); Pain (1994); Pulmonary Infarction (2021); Tachycardia (2095); Urinary Retention (2119); Vomiting (2144); Chills (2191); Hernia (2240); Obstruction/Occlusion (2422); Ascites (2596); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for laparoscopic therapeutic treatment of an incisional hernia.It was reported that after implant, the patient experienced infection, segmental pulmonary emboli, atelectasis, slowly improving tachycardia, diarrhea, recurrence, oliguria [abnormally small amounts of urine], pain, nausea, vomiting, fever, chills, small bowel obstruction, pulmonary infarcts, inflammation, air-fluid collection, and ileus.Post-operative patient treatment included revision surgery, picc line placed, ng tube, therapeutic anticoagulation for pe, iv hydration, analgesics, hernia repair with new mesh, admission to hospital, antiemetic, lysis of adhesions, drain in place, and mesh removal.

• Brand Name: SYMBOTEX
• 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: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 12320951
• MDR Text Key: 266487127
• Report Number: 9615742-2021-01948
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521190344
• UDI-Public: 10884521190344
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142908
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Model Number: SYM12
• Device Catalogue Number: SYM12
• Device Lot Number: PPK0838X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/28/2021
• Date Device Manufactured: 12/12/2015
• 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): Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 87