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

Model Number PCO1510

Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993); Material Split, Cut or Torn (4008)

Patient Problems Wound Dehiscence (1154); Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Bacterial Infection (1735); Cellulitis (1768); Purulent Discharge (1812); Erythema (1840); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Itching Sensation (1943); Muscle Weakness (1967); Nausea (1970); Necrosis (1971); Pain (1994); Staphylococcus Aureus (2058); Scar Tissue (2060); Scarring (2061); Seroma (2069); Chills (2191); Discharge (2225); Hernia (2240); Ulcer (2274); Discomfort (2330); Injury (2348); Impaired Healing (2378); Ascites (2596); Abdominal Distention (2601); Fluid Discharge (2686); Fibrosis (3167); No Code Available (3191); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

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.

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 preoperative and postoperative diagnosis was ventral incisional hernia.The patient underwent a laparoscopic ventral incisional hernia repair with underlying composite mesh (underlay).The patient underwent an additional implant surgery approximately 1 year and 6 months post op.The patient underwent multiple revision surgeries in 2013 and 2014.The patient experienced migration, infection, incision and drainage, and explant of mesh.

Manufacturer Narrative

(b)(4).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.Product was used for laparoscopic therapeutic treatment of a ventral incisional hernia repair.It was reported that after underlay implant, the patient experienced recurrence, adhesions, migration, abscess, non-healing wound, (b)(6) infection, fluid collection, pain, bulge, wound dehiscence, drainage wound, foul purulent liquified material, feculent material, necrosis, phlegmon,serosanguineous fluid, nonhealing ventral abdominal wound, scarring, seroma, infection, abdominal pain, bulge, mesh torn and bacterial infection.Post-operative patient treatment included revisions surgery to explant mesh, adhesions taken down, incision and drainage, wound vac, debridement of abdominal wound, and implant additional mesh.

Manufacturer Narrative

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

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.Product was used for laparoscopic therapeutic treatment of a ventral incisional hernia repair.It was reported that after underlay implant, the patient experienced recurrence, adhesions, migration, abscess, non-healing wound, (b)(6) infection, fluid collection, pain, bulge, wound dehiscence, drainage wound, foul purulent liquified material, feculent material, necrosis, serosanguineous fluid, nonhealing ventral abdominal wound, scarring, seroma, infection, abdominal pain, bulge, and bacterial infection.Post-operative patient treatment included revisions surgery to explant mesh, adhesions taken down, incision and drainage, wound vac, debridement of abdominal wound, and implant additional mesh.

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.Product was used for laparoscopic therapeutic treatment of a ventral incisional hernia repair.It was reported that after underlay implant, the patient experienced recurrence, adhesions, migration, abscess, non-healing wound, (b)(6) infection, and infection.Post-operative patient treatment included revisions surgery to explant mesh, adhesions taken down, incision and drainage, wound vac, debridement of abdominal wound, and implant additional mesh.

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

Event Description

The patient's attorney alleged a deficiency against the device.Product was used for therapeutic treatment.The patient underwent a laparoscopic ventral incisional hernia repair with underlying composite mesh (underlay).It was reported that after underlay implant, the patient experienced recurrence, adhesions, migration, and infection.Post-operative patient treatment included revisions surgery to explant mesh and implant additional mesh.

Manufacturer Narrative

Additional info: b5, b7, g1, h6 (all codes) correction: a4 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.

Event Description

The patient's attorney alleged a deficiency against the device.Product was used for laparoscopic therapeutic treatment of a ventral incisional hernia repair.It was reported that after underlay implant, the patient experienced inflammation, sinus tract, scar tissue, no stomach muscle, back issues, recurrence, adhesions, migration, abscess, non-healing wound, mssa infection, fluid collection, pain, bulge, wound dehiscence, drainage wound, foul purulent liquified material, feculent material, necrosis, phlegmon, serosanguineous fluid, nonhealing ventral abdominal wound, scarring, seroma, infection, abdominal pain, bulge, mesh torn and bacterial infection.Post-operative patient treatment included medication, revisions surgery to explant mesh, adhesions taken down, incision and drainage, wound vac, use of drain, debridement of abdominal wound, and implant additional mesh.

Event Description

The patient's attorney alleged a deficiency against the device.Product was used for laparoscopic therapeutic treatment of a ventral incisional hernia repair.It was reported that after underlay implant, the patient experienced inflammation, sinus tract, scar tissue, no stomach muscle, back issues, recurrence, adhesions, migration, abscess, non-healing wound, mssa infection, fluid collection, pain, bulge, wound dehiscence, drainage wound, foul purulent liquified material, feculent material, necrosis, phlegmon, serosanguineous fluid, nonhealing ventral abdominal wound, scarring, seroma, infection, abdominal pain, bulge, mesh torn, ulcer, granulation tissue, fibrosis, itching, chills, malaise, nausea, bloody white drainage, ulceration, erythema, tenderness, induration, edema, cellulitis, staphylococcus aureus, and bacterial infection.Post-operative patient treatment included medication, revisions surgery to explant mesh, adhesions taken down, incision and drainage, wound vac, use of drain, debridement of abdominal wound, ct scan, admission to hospital, ultrasound guided aspiration, and implant additional mesh.

Manufacturer Narrative

Additional information: h6 (added patient and imf codes) ime 2402: sinus tract, feculent material, induration.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.

• Brand Name: MESH SOFRADIM- PARIETEX 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 ; 8200 coral sea st ne; mounds view,mn, CT 55112 ; 7635265677
• MDR Report Key: 6886686
• MDR Text Key: 87160230
• Report Number: 9615742-2017-05340
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/08/2022

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 Model Number: PCO1510
• Device Catalogue Number: PCO1510
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/25/2017
• Initial Date FDA Received: 09/22/2017
• Supplement Dates Manufacturer Received: 05/29/2019; 05/15/2019; 05/15/2019; 01/15/2020; 01/22/2020; 09/07/2022; 11/16/2022
• Supplement Dates FDA Received: 10/03/2019; 11/11/2019; 01/08/2020; 01/22/2020; 01/28/2020; 09/15/2022; 12/08/2022
• 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
• Treatment: UNKABSTACK(LOT#: UNKNOWN).
• Patient Outcome(s): Hospitalization; Required Intervention; Other
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Weight: 123 KG
• Patient Race: White