MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX¿ OPTIMIZED COMPOSITE MESH; MESH, SURGICAL, POLYMERIC

Model Number PCO2015X

Device Problems Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Purulent Discharge (1812); Emotional Changes (1831); Fistula (1862); Failure of Implant (1924); Unspecified Infection (1930); Inflammation (1932); Nausea (1970); Necrosis (1971); Pain (1994); Vomiting (2144); Cramp(s) (2193); Hernia (2240); Injury (2348); Impaired Healing (2378); Obstruction/Occlusion (2422); No Code Available (3191); Constipation (3274); Cramp(s) /Muscle Spasm(s) (4521); 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 resulting in an unspecified adverse outcome.Product was used for therapeutic treatment.The patient underwent a ventral hernia repair with mesh.He had revision surgery but the time line was not given on the source documentation.The patient experienced infection, hernia recurrence.A physician has recommended surgical intervention.

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 ventral hernia.It was reported that after implant, the patient experienced adhesions, infection, abscess, wound dehiscence, fascial necrosis, open wound, obstruction, mildly diffuse prominence, abdominal pain, vomiting bile, no bowel movement for two weeks, cramping, pain, nausea, fistula, necrosis, purulent fluid, hernia recurrence, mental pain, physical pain, suffering, disability, impairment, loss of enjoyment of life, defective device, and failure of mesh.Post-operative patient treatment included revision surgery, wound vac placement, recurrence repair, sigmoid colectomy, component separation, abdominal wound washout, apply abdominal wall retention suture, debridement of abscess, and extensive lysis of adhesions.

Manufacturer Narrative

This information was received as a part of an extensive mesh litigation submission to medtronic.The fda was notified of this large complaint receipt.Due to the volume of complaint information received by medtronic, this resulted in a report beyond the 30 day target.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 therapeutic treatment of a ventral hernia.It was reported that after implant, the patient experienced adhesions, infection, abscess, wound dehiscence, fascial necrosis, open wound, hernia recurrence.Post-operative patient treatment included revision surgery, wound vac placement, recurrence repair and extensive lysis of adhesions.

Event Description

The patient's attorney alleged a deficiency against the device.The product was used for laparoscopic therapeutic treatment of a ventral hernia.It was reported that after implant, the patient experienced adhesions, infection, abscess, wound dehiscence, fascial necrosis, open wound, obstruction, mildly diffuse prominence, abdominal pain, vomiting bile, no bowel movement for two weeks, cramping, pain, nausea, fistula, necrosis, purulent fluid, and hernia recurrence.Post-operative patient treatment included revision surgery, wound vac placement, recurrence repair, sigmoid colectomy, component separation, abdominal wound washout, apply abdominal wall retention suture, debridement of abscess, and extensive lysis of adhesions.

Manufacturer Narrative

This information was received as a part of an extensive mesh litigation submission to medtronic.The fda was notified of this large complaint receipt.Due to the volume of complaint information received by medtronic, this resulted in a report beyond the 30 day target.Additional information: a1, a3, a5b, b5, b6, b7, e3, e4(email), g4, h6.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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

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 Description

The patient's attorney alleged a deficiency against the device.The product was used for laparoscopic therapeutic treatment of a ventral hernia.It was reported that after implant, the patient experienced edematous colon mucosa, inflammation, fascial dehiscence, adhesions, infection, abscess, wound dehiscence, fascial necrosis, open wound, obstruction, mildly diffuse prominence, abdominal pain, vomiting bile, no bowel movement for two weeks, cramping, pain, nausea, fistula, necrosis, purulent fluid, hernia recurrence, mental pain, physical pain, suffering, disability, impairment, loss of enjoyment of life, defective device, and failure of mesh.Post-operative patient treatment included ct scan, barium enema, exploratory laparotomy, revision surgery, wound vac placement, recurrence repair, sigmoid colectomy, end colostomy, component separation, abdominal wound washout, apply abdominal wall retention suture, use of blake drain, debridement of abscess, removal of mesh, hernia repair with new mesh, and extensive lysis of adhesions.

• Brand Name: MESH SOFRADIM - PARIETEX¿ OPTIMIZED COMPOSITE MESH
• 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 ; 5920 longbow drive; 8200 coral sea st ne; mounds view,mn, CO 55112 ; 7635265677
• MDR Report Key: 7449737
• MDR Text Key: 106138184
• Report Number: 9615742-2018-00970
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521179769
• UDI-Public: 10884521179769
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110815
• 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,Followup,Followup
• Report Date: 07/15/2024

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
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Model Number: PCO2015X
• Device Catalogue Number: PCO2015X
• Device Lot Number: PNK0083X
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/23/2018
• Initial Date FDA Received: 04/22/2018
• Supplement Dates Manufacturer Received: 06/12/2019; 06/12/2019; 09/22/2021; 07/10/2024
• Supplement Dates FDA Received: 01/09/2020; 02/18/2020; 10/12/2021; 07/15/2024
• Date Device Manufactured: 11/14/2013
• 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): Disability; Required Intervention; Other
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 102 KG
• Patient Race: Black Or African American, White