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

Model Number PCO2015

Device Problems Migration or Expulsion of Device (1395); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Bacterial Infection (1735); Purulent Discharge (1812); Edema (1820); Emotional Changes (1831); Erythema (1840); Fatigue (1849); Fever (1858); Fistula (1862); Foreign Body Reaction (1868); Hematoma (1884); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Staphylococcus Aureus (2058); Scar Tissue (2060); Seroma (2069); Swelling (2091); Burning Sensation (2146); Discharge (2225); Viral Infection (2248); Discomfort (2330); Injury (2348); Impaired Healing (2378); Ascites (2596); Blood Loss (2597); Ptosis (2620); Fluid Discharge (2686); 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

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 hernia.It was reported that after implant, the patient experienced chronic pain, infection, and an abscess.Treatment required includes revision and infected mesh removal approximately one year after implant.

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.(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.The product was used for therapeutic treatment of an incisional hernia.It was reported that after implant, the patient experienced mesh migration, fistula, chronic pain, open wound, infection, (b)(6), fluid collection, seroma, prominent lymph nodes, positive cocci, viral infection, hematoma, inflammation, phlegmon, bleeding, diffuse oozing, abdominal pain, fever, redness, tenderness, serosanguineous fluid, slurred speech, ptosis, swelling, blister, fatigue, burning pain, scar tissue, sinus tract, purulent material, mesh partial separated, serous drainage, erythema, granulation tissue, induration, non-feculent drainage, edema, and an abscess.Post-operative patient treatment included revision surgery, wound vac, panniculectomy, evacuation of hematoma, drains placed, transferred to icu, 2 units of packed red blood cells, aspiration of pelvic fluid collections, antibiotics, admitted to hospital, incision and drainage of subcutaneous tissue, medications, picc line placed and then removed, drain removed, suture and tack removed, removal of abscess rind in cavity, and infected mesh removal.

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.The product was used for therapeutic treatment of an incisional hernia.It was reported that after implant, the patient experienced mesh migration, fistula, chronic pain, open wound, infection, and an abscess.Treatment required includes revision, wound vac, and infected mesh removal approximately one year after implant.

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 of an incisional hernia.It was reported that after implant, the patient experienced mental pain, disability, impairment, loss of enjoyment of life, defective mesh, mesh migration, fistula, chronic pain, open wound, infection, mrsa, fluid collection, seroma, prominent lymph nodes, positive cocci, viral infection, hematoma, inflammation, phlegmon, bleeding, diffuse oozing, abdominal pain, fever, redness, tenderness, serosanguineous fluid, slurred speech, ptosis, swelling, blister, fatigue, burning pain, scar tissue, sinus tract, purulent material, mesh partial separated, serous drainage, erythema, granulation tissue, induration, non-feculent drainage, edema, and an abscess.Post-operative patient treatment included revision surgery, additional implant, wound vac, panniculectomy, evacuation of hematoma, drains placed, transferred to icu, 2 units of packed red blood cells, aspiration of pelvic fluid collections, antibiotics, admitted to hospital, incision and drainage of subcutaneous tissue, medications, picc line placed and then removed, drain removed, suture and tack removed, removal of abscess rind in cavity, and infected mesh removal.

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 an incisional hernia.It was reported that after implant, the patient experienced mental pain, disability, impairment, loss of enjoyment of life, defective mesh, mesh migration, fistula, chronic pain, open wound, infection, mrsa, fluid collection, seroma, prominent lymph nodes, positive cocci, viral infection, hematoma, inflammation, phlegmon, bleeding, diffuse oozing, abdominal pain, fever, redness, tenderness, serosanguineous fluid, slurred speech, ptosis, swelling, blister, fatigue, burning pain, scar tissue, sinus tract, purulent material, mesh partial separated, serous drainage, erythema, granulation tissue, induration, non-feculent drainage, edema, an abscess, granulomatous response, mesh free floating.Post-operative patient treatment included ct scan, revision surgery, additional implant, wound vac, panniculectomy, evacuation of hematoma, drains placed, transferred to icu, 2 units of packed red blood cells, aspiration of pelvic fluid collections, antibiotics, admitted to hospital, incision and drainage of subcutaneous tissue, medications, picc line placed and then removed, drain removed, suture and tack removed, removal of abscess rind in cavity, and infected mesh removal.

Manufacturer Narrative

Additional information: b5, b7, e1(facility name, street 1, city, region, postal code), additional 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.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 an incisional hernia.It was reported that after implant, the patient experienced mental pain, disability, impairment, loss of enjoyment of life, defective mesh, mesh migration, fistula, chronic pain, open wound, infection, mrsa, fluid collection, seroma, prominent lymph nodes, positive cocci, viral infection, hematoma, inflammation, phlegmon, bleeding, diffuse oozing, abdominal pain, fever, redness, tenderness, serosanguineous fluid, slurred speech, ptosis, swelling, blister, fatigue, burning pain, scar tissue, sinus tract, purulent material, mesh partial separated, serous drainage, erythema, granulation tissue, induration, non-feculent drainage, edema, an abscess, granulomatous response, <(>&<)> mesh free floating.Post-operative patient treatment included ct scan, revision surgery, additional implant, wound vac, panniculectomy, evacuation of hematoma, drains placed, transferred to icu, 2 units of packed red blood cells, aspirationof pelvic fluid collections, antibiotics, admitted to hospital, incision and drainage of subcutaneous tissue, medications, picc line placed and then removed, drain removed, suture and tack removed, removal of abscess rind in cavity, hernia repair with new mesh, and infected mesh removal.Relevant tests/laboratory data: (b)(6) 2012: nasal swab positive as an mrsa carrier.(b)(6) 2012: er report- ct abdomen/pelvis- 7cm fluid collection deep to lower abdominal wall, anterior to urinary bladder suspicious for abscess/seroma.Also, superficial lower abdominal fluid collection in region of drain could represent abscess/seroma.(b)(6) 2012: ct noted fluid collections with prominent lymph nodes.(b)(6) 2012: cultures positive for heavy growth of staphylococcus aureus and gram stain showed moderate gram-positive cocci in pairs.(b)(6) 2012: progress note- urine tox screen returned positive for methamphetamine use (b)(6) 2012: viral culture of outbreak on left buttock found to be hsv2 (genital herpes simplex).(b)(6) 2013: limited abdominal ultrasound noted 11cm soft tissue collection in the anterior bowel wall, possible hematoma or abscess.-ct abdomen/pelvis noted persistent anterior abdominal wall fluid collection representing seroma or hematoma (b)(6) 2013: wound cultures positive for scant mrsa.(b)(6) 2013: ct abdomen/pelvis- rectus abdominis muscle fluid collection unchanged from (b)(6) 2013.Anterior fluid collection smaller.(b)(6) 2013: ct abdomen/pelvis- 2 small fluid collections in the anterior midline abdominal wall unchanged.Fluid collections are s maller.(b)(6) 2013: ct abdomen/pelvis- extensive inflammatory soft tissue phlegmon and 2 small developing abscesses.(b)(6)2017: ct abdomen/pelvis- progressive wall thickening at lower midline abdominal wall at site of ventral hernia repair.

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 an incisional hernia.It was reported that after implant, the patient experienced mental pain, disability, impairment, loss of enjoyment of life, defective mesh, mesh migration, fistula, chronic pain, open wound, infection, mrsa, fluid collection, seroma, prominent lymph nodes, positive cocci, hematoma, inflammation, phlegmon, bleeding, diffuse oozing, abdominal pain, fever, redness, tenderness, serosanguineous fluid, slurred speech, ptosis, swelling, blister, fatigue, burning pain, scar tissue, sinus tract, purulent material, mesh partial separated, serous drainage, erythema, granulation tissue, induration, non-feculent drainage, edema, an abscess, granulomatous response, mesh free floating, adhesions.Post-operative patient treatment included ct scan, revision surgery, additional implant, wound vac, panniculectomy, evacuation of hematoma, drains placed, transferred to icu, 2 units of packed red blood cells, aspiration of pelvic fluid collections, antibiotics, admitted to hospital, incision and drainage of subcutaneous tissue, medications, picc line placed and then removed, drain removed, suture and tack removed, removal of abscess rind in cavity, hernia repair with new mesh, and infected mesh removal.

• 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; 8200 coral sea st ne; mounds view,mn, CT 55112 ; 7635265677
• MDR Report Key: 8009822
• MDR Text Key: 125166967
• Report Number: 9615742-2018-02452
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050187
• 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: 11/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/30/2016
• Device Model Number: PCO2015
• Device Catalogue Number: PCO2015
• Device Lot Number: PLK00310
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/01/2023
• Date Device Manufactured: 11/23/2011
• 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: UNK PROTACK(LOT#: UNKNOWN)
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Weight: 83 KG
• Patient Race: White