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

Model Number SYM3728

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

Patient Problems Adhesion(s) (1695); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Muscle Weakness (1967); Pain (1994); Seroma (2069); Swelling (2091); Weakness (2145); Discharge (2225); Hernia (2240); Distress (2329); Injury (2348); Numbness (2415); Abdominal Distention (2601); No Code Available (3191); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)

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 therapeutic treatment.It was reported that after a hernia procedure where this device was implanted, the patient experienced multiple surgical revisions, large fluctuating mass underneath surgical incision consistent with postoperative seroma, incision and drainage, aspiration, left flank hernia recurrence, open left myofascial advancement flap, removal of parietex mesh in its entirety, lysis of adhesions, sigmoid and colon adhered to symbotex mesh.After the original procedure, additional potentially related procedures were performed, including removal.

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 incisional hernia.It was reported that after a hernia procedure where this device was implanted, the patient experienced multiple surgical revisions, large fluctuating mass underneath surgical incision consistent with postoperative infection, seroma, incision and drainage, aspiration, left flank hernia recurrence, open left myofascial advancement flap, removal of parietex mesh in its entirety, lysis of adhesions, sigmoid and colon adhered to symbotex mesh.After the original procedure, additional potentially related procedures were performed, including placement of new 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.The product was used for therapeutic treatment of incisional hernia.It was reported that after a hernia procedure where this device was implanted, the patient experienced swelling, pain, seroma, infection, sero-hemorrhagic fluid, bulge, numbness, pain with sexual activity, rectal diastases, recurrence, adhesions, and open left myofascial advancement flap.Post-operative patient treatment included revision surgery, drainage of seroma and sero-hemorrhagic fluid, incision and drainage, aspiration, removal of parietex mesh in its entirety, lysis of adhesions, placement of new mesh.

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of incisional hernia.It was reported that after a hernia procedure where this device was implanted, the patient experienced weakness, swelling, pain, seroma, infection, sero-hemorrhagic fluid, bulge, numbness, pain with sexual activity, rectal diastases, recurrence, adhesions, and open left myofascial advancement flap.Post-operative patient treatment included revision surgery, drainage of seroma and sero-hemorrhagic fluid, incision and drainage, aspiration, removal of parietex mesh in its entirety, lysis of adhesions, placement of new mesh.Relevant tests/laboratory data, including dates 08 aug 2016: progress note- ct guided aspiration showed no evidence of significant intra-abdominal pathology.Microbiology analysis was negative for infection.No signs of hernia recurrence were noted.- relevant tests/laboratory data: (b)(6) 2016: office visit- abdominal ct demonstrated no evidence of significant disruption of previous repair with small area of weakness posteriorly and resolving seroma.Aspiration with ct guidance of seroma was completed.On (b)(6) 2020: ct of abdomen/pelvis: stable small fat containing ventral hernia and left rectus muscle atrophy noted with possible relation to prior hernia repair.

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.Additional information: b7, g4.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

Corrected information: h6(verbatim for code c64343) h6 patient codes - c64343 (rectal diastases) 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.The product was used for therapeutic treatment of incisional hernia.It was reported that after a hernia procedure where this device was implanted, the patient experienced weakness, swelling, pain, seroma, infection, sero-hemorrhagic fluid, bulge, numbness, pain with sexual activity, rectal diastases, recurrence, adhesions, and open left myofascial advancement flap.Post-operative patient treatment included revision surgery, drainage of seroma and sero-hemorrhagic fluid, incision and drainage, aspiration, removal of parietex mesh in its entirety, lysis of adhesions, placement of new mesh.

Manufacturer Narrative

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.The product was used for therapeutic treatment of incisional hernia.It was reported that after a hernia procedure where this device was implanted, the patient experienced weakness, left rectus muscle atrophy, swelling, pain, seroma, infection, sero-hemorrhagic fluid, bulge, numbness, pain with sexual activity, rectal diastases, recurrence, adhesions, emotional distress, and open left myofascial advancement flap.Post-operative patient treatment included revision surgery, drainage of seroma and sero-hemorrhagic fluid, incision and drainage, aspiration, removal of parietex mesh in its entirety, lysis of adhesions, ct scan, placement of new mesh.

• 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: 7555277
• MDR Text Key: 109609772
• Report Number: 9615742-2018-01210
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521190566
• UDI-Public: 10884521190566
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131969
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/27/2024

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: 09/30/2016
• Device Model Number: SYM3728
• Device Catalogue Number: SYM3728
• Device Lot Number: PNJ0187X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/02/2018
• Initial Date FDA Received: 05/30/2018
• Supplement Dates Manufacturer Received: 05/15/2019; 05/15/2019; 06/05/2019; 04/10/2020; 05/13/2020; 02/21/2024
• Supplement Dates FDA Received: 08/18/2019; 09/23/2019; 01/27/2020; 05/08/2020; 05/28/2020; 02/27/2024
• Date Device Manufactured: 10/24/2013
• 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
• Treatment: UNKNOWN PARIETEX (LOT# UNKNOWN)
• Patient Outcome(s): Required Intervention; Other
• Patient Sex: Male