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

Model Number	SYM15
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Abdominal Pain (1685); Adhesion(s) (1695); Foreign Body Reaction (1868); Hemorrhage/Blood Loss/Bleeding (1888); Inflammation (1932); Ischemia (1942); Nausea (1970); Necrosis (1971); Pain (1994); Seroma (2069); Vomiting (2144); Electrolyte Imbalance (2196); Hernia (2240); Obstruction/Occlusion (2422); Ascites (2596); Constipation (3274); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
The patient's attorney alleged a deficiency against the device.The product was used for therapeutic treatment of a ventral hernia.It was reported that after implant, the patient experienced mesh migration, pain, recurrence, adhesions, obstruction, small bowel entrapment, and on disability now due to severe bowel problems stemming from last hernia.Post-operative patient treatment included hernia repair with new mesh, small bowel resection, appendectomy, robotic laparoscopy, hernia repair, release of small bowel obstruction, laparoscopy converted to exploratory laparotomy, lysis of adhesions, excision of posterior rectus sheath, and small bowel resection with primary anastomosis.
Additional Manufacturer Narrative
Additional info: a1, a4, a5b, b2, b5, b6, b7, d10 (covidien, product id - abstack30, lot # - n9c0379y), <(>&<)> h6 (patient codes, ime e2402:small bowel entrapment, ileus, labs abnormal for hemoglobin;hematocrit, protein calorie malnutrition) medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
The patient's attorney alleged a deficiency against the device.The product was used for therapeutic treatment of a ventral hernia.It was reported that after implant, the patient experienced mesh migration, pain, recurrence, adhesions, obstruction, small bowel entrapment, on disability now due to severe bowel problems stemming from last hernia, ileus, fluid collection, seroma, constipation, labs abnormal for hemoglobin; hematocrit, fascia dehisced, inflammation, reactive soft tissue, nausea, vomiting, abdominal pain, bloody serosanguinous fluid in abdomen, ischemic <(>&<)> necrotic small bowel, acute blood loss anemia, hemorrhage, electrolyte imbalance, <(>&<)> protein calorie malnutrition.Post-operative patient treatment included hernia repair with new mesh, small bowel resection, appendectomy, robotic laparoscopy, hernia repair, release of small bowel obstruction, laparoscopy converted to exploratory laparotomy, lysis of adhesions, excision of posterior rectus sheath, small bowel resection with primary anastomosis, x-ray, ct scan, pt, use of jp drain, drainage of seroma, multiple hospitalizations, placement of ng tube, oral antibiotics, iv antibiotics, drainage of serosanguinous fluid, blood transfusion, iv iron, <(>&<)> electrolyte repletion.

• Brand Name: SYMBOTEX
• Common Device Name: 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: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 19222595
• Report Number: 9615742-2024-00622
• Device Sequence Number: 15502460
• Product Code: FTL
• UDI-Device Identifier: 10884521190368
• UDI-Public: 10884521190368
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K142908
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: SYM15
• Device Catalogue Number: SYM15
• Device Lot Number: PSL0202X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2024
• Supplement Date Received by Manufacturer: 07/17/2024
• Initial Report FDA Received Date: 05/01/2024
• Supplement Report FDA Received Date: 07/25/2024
• Date Device Manufactured: 12/20/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 COMMENT
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Disability
• Patient Sex: Female
• Patient Weight: 162 KG
• Patient Race: White