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

Model Number SYM9

Device Problems Migration or Expulsion of Device (1395); Detachment of Device or Device Component (2907); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Diarrhea (1811); Emotional Changes (1831); Fever (1858); Unspecified Infection (1930); Inflammation (1932); Nausea (1970); Nerve Damage (1979); Pain (1994); Vomiting (2144); Hernia (2240); Ulcer (2274); Obstruction/Occlusion (2422); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); 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 a incisional hernia.It was reported that after implant, the patient experienced extreme pain, abdominal pain, vomiting, 20-30 episodes of diarrhea per day, omental adhesions to mesh, appendix inflammation, chronic inflammation from mesh, malnourishment, 100-degree fever, marginal ulcer, suffering, injury, and mental pain, and fragmented mesh.Post-operative patient treatment included multiple emergency room visits, transnasal esophagoscopy, lysis of adhesions, hernia repair, ct scan, appendectomy, peripherally inserted central catheter ("picc") placement in arm for malnourishment, admission to the hospital, diagnostic laparoscopy, upper endoscopy, and mesh removal.

Manufacturer Narrative

Additional info: a2 (date of birth), b5, b7, e1 (facility name, street, city, region, postal code), g1, h6 (patient codes, ime codes, imf codes, device codes).Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for laparoscopic therapeutic treatment of a incisional hernia.It was reported that after implant, the patient experienced nausea, abscess, bowel obstruction, nerve damage, mesh migration, mesh shrinkage, infection, hernia, extreme pain, abdominal pain, vomiting, 20-30 episodes of diarrhea per day, omental adhesions to mesh, appendix inflammation, chronic inflammation from mesh, malnourishment, 100-degree fever, marginal ulcer, suffering, injury, and mental pain, and fragmented mesh.Post-operative patient treatment included additional device required, bowel/intestinal removal, multiple emergency room visits, transnasal esophagoscopy, lysis of adhesions, hernia repair, ct scan, appendectomy, peripherally inserted central catheter ("picc") placement in arm for malnourishment, admission to the hospital, diagnostic laparoscopy, upper endoscopy, and mesh removal.

Manufacturer Narrative

Additional info: h6 (patient code).Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for laparoscopic therapeutic treatment of a incisional hernia.It was reported that after implant, the patient experienced edema, nausea, abscess, bowel obstruction, nerve damage, mesh migration, mesh shrinkage, infection, hernia, extreme pain, abdominal pain, vomiting, 20-30 episodes of diarrhea per day, omental adhesions to mesh, appendix inflammation, chronic inflammation from mesh, malnourishment, 100-degree fever, marginal ulcer, suffering, injury, and mental pain, and fragmented mesh.Post-operative patient treatment included esophagogastroduodenoscopy, additional device required, bowel/intestinal removal, multiple emergency room visits, transnasal esophagoscopy, lysis of adhesions, hernia repair, ct scan, appendectomy, peripherally inserted central catheter ("picc") placement in arm for malnourishment, admission to the hospital, diagnostic laparoscopy, upper endoscopy, 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: justin ellis ; 60 middletown ave.; 8200 coral sea st ne; mounds view,mn, CT 55112 ; 7635265677
• MDR Report Key: 11322243
• MDR Text Key: 231624753
• Report Number: 9615742-2021-00343
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521190634
• UDI-Public: 10884521190634
• 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,Followup,Followup
• Report Date: 02/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: SYM9
• Device Catalogue Number: SYM9
• Device Lot Number: PSC1154X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/15/2023
• Date Device Manufactured: 04/07/2018
• 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 Sex: Female
• Patient Weight: 79 KG