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

Model Number PCO2520OS

Device Problems 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); Erosion (1750); Purulent Discharge (1812); Fistula (1862); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Muscle Weakness (1967); Nausea (1970); Nerve Damage (1979); Pain (1994); Perforation (2001); Sepsis (2067); Seroma (2069); Vomiting (2144); Peritonitis (2252); Obstruction/Occlusion (2422); Ascites (2596); Fluid Discharge (2686); Unspecified Tissue Injury (4559)

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 an incisional hernia.It was reported that after the underlay implant, the patient experienced adhesions, small bowel friable/oozing blood, bowel loops fistulized, infection, enterotomy, mesh erosion, dilated loops of small bowel, fluid collection, abscess, gram +cocci, rare klebsiella pneumoniae, few streptococcus viridans, abdominal pain, nausea, vomiting, peritonitis, and purulent material.Post-operative patient treatment included resection of bowel, lysis of adhesions, drainage of abscess, given keentra fresh and frozen plasma [ffp] to reverse anticoagulation, and removal of mesh.

Manufacturer Narrative

Additional information: b5, d4 (lot number), g3, 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.

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 the underlay implant, the patient experienced adhesions, small bowel friable/oozing blood, bowel loops fistulized, infection, mesh erosion, dilated loops of small bowel, fluid collection, abscess, gram +cocci, rare klebsiella pneumoniae, few streptococcus viridans, abdominal pain, nausea, vomiting, peritonitis, bowel obstruction, pain, nerve damage, sepsis, and purulent material.Post-operative patient treatment included resection of bowel, lysis of adhesions, enterotomy, drainage of abscess, given keentra fresh & frozen plasma [ffp] to reverse anticoagulation, and removal of mesh.

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 the underlay implant, the patient experienced perforation, drainage, inflammation, adhesions, small bowel friable/oozing blood, bowel loops fistulized, infection, mesh erosion, dilated loops of small bowel, fluid collection, abscess, gram +cocci, rare klebsiella pneumoniae, few streptococcus viridans, abdominal pain, nausea, vomiting, peritonitis, bowel obstruction, pain, nerve damage, sepsis, and purulent material.Post-operative patient treatment included cat-scan, jp drains, medication, resection of bowel, lysis of adhesions, enterotomy, drainage of abscess, given keentra fresh frozen plasma [ffp] to reverse anticoagulation, and removal of mesh.Relevant tests/laboratory data: 24 nov 2018: per op note, cat scan reveals dilated loops of small bowel with transition point in pelvis associated fluid collection around abdominal wall mesh.24 nov 2018: lab report of intra abdominal abscess resulted in rare polys, few gram +cocci, few gram ¿ rods, rare klebsiella pneumoniae, few streptococcus viridans.

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.

Manufacturer Narrative

Additional codes 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.

Manufacturer Narrative

Additional information: h6 (patient codes), additional codes 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 therapeutic treatment of an incisional hernia.It was reported that after the underlay implant, the patient experienced perforation, seroma, drainage, inflammation, adhesions, small bowel friable/oozing blood, fistulas, infection, mesh erosion, fluid collection, enterotomy, abscess, gram +cocci, rare klebsiella pneumoniae, few streptococcus viridans, abdominal pain, nausea, vomiting, peritonitis, bowel obstruction, pain, nerve damage, sepsis, discharge, and purulent discharge.Post-operative patient treatment included cat-scan, jp drains, medication, resection of bowel, lysis of adhesions, drainage of abscess, given keentra fresh frozen plasma [ffp] to reverse anticoagulation, hospitalization, and removal of mesh.Relevant tests/laboratory data: on (b)(6) 2018: per op note, cat scan reveals dilated loops of small bowel with transition point in pelvis associated fluid collection around abdominal wall mesh.On (b)(6) 2018: lab report of intra abdominal abscess resulted in rare polys, few gram +cocci, few gram ¿ rods, rare klebsiella pneumoniae, few streptococcus viridans.

• 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 ; 5920 longbow drive; 8200 coral sea st ne; mounds view,mn, CO 55112 ; 7635265677
• MDR Report Key: 12254066
• MDR Text Key: 264347531
• Report Number: 9615742-2021-01862
• 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: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/02/2024

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: 08/31/2013
• Device Model Number: PCO2520OS
• Device Catalogue Number: PCO2520OS
• Device Lot Number: PH00258
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/14/2021
• Initial Date FDA Received: 07/30/2021
• Supplement Dates Manufacturer Received: 12/08/2021; 12/08/2021; 07/17/2024; 07/24/2024
• Supplement Dates FDA Received: 12/27/2021; 11/04/2022; 07/24/2024; 08/02/2024
• 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 PROTACK (LOT#UNKNOWN).; UNKNOWN PROTACK (LOT#UNKNOWN)
• Patient Outcome(s): Required Intervention; Life Threatening; Hospitalization
• Patient Sex: Male
• Patient Weight: 143 KG