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

Model Number TEM2015G

Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Abdominal Pain (1685); Abscess (1690); Anemia (1706); Bacterial Infection (1735); Cellulitis (1768); Chest Pain (1776); Diarrhea (1811); Purulent Discharge (1812); Dyspnea (1816); Fatigue (1849); Gastritis (1874); Unspecified Infection (1930); Inflammation (1932); Muscle Weakness (1967); Nausea (1970); Pain (1994); Swelling (2091); Vomiting (2144); Weakness (2145); Chills (2191); Dizziness (2194); Hernia (2240); Discomfort (2330); Injury (2348); Deformity/ Disfigurement (2360); Impaired Healing (2378); Obstruction/Occlusion (2422); Post Operative Wound Infection (2446); No Code Available (3191); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

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 resulting in an unspecified adverse outcome.Product was used for therapeutic treatment.The patient underwent a ventral hernia repair with mesh.The patient has alleged permanent mental and physical pain, permanent injuries including abdominal pain and swelling has undergone and will under go corrective surgeries.

Manufacturer Narrative

Medtronic complaint report: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Per additional information received, approximately 3 weeks after implant, the patient was re-admitted to hospital with purulent damage from the incision following the open ventral hernia repair.The mesh had become infected and peeled off the abdominal wall.The patient was started on iv antibiotics.Patient required repeated wound care changes.The mesh was surgically removed.Abscesses had formed in patients abdominal cavity.

Manufacturer Narrative

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

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 in an open ventral hernia as well as repair of enterotomy.During the procedure, dense adhesions were noted throughout the abdomen and the small bowel was densely adhered to the left lateral sidewall.An enterotomy was encountered.The size of the hernia caused the procedure to convert to open.Approximately 3 weeks after implant, the patient was re-admitted to hospital with purulent damage from the incision following the open ventral hernia repair.The mesh had become infected and peeled off the abdominal wall.The patient was started on iv antibiotics.Patient required repeated wound care changes.The mesh was surgically removed.Abscesses had formed in patient¿s abdominal cavity.The surgeon reported that the mesh was not the source of the infection, but post-surgical noncompliance.The patient has alleged permanent mental and physical pain, permanent injuries including abdominal pain and swelling has undergone and will undergo corrective surgeries.

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 in an open ventral hernia as well as repair of enterotomy.During the procedure, dense adhesions were noted throughout the abdomen and the small bowel was densely adhered to the left lateral sidewall.An enterotomy was encountered.The size of the hernia caused the procedure to convert to open.Approximately 3 weeks after implant, the patient was re-admitted to hospital with purulent damage from the incision following the open ventral hernia repair.The mesh had become infected and peeled off the abdominal wall.The patient was started on iv antibiotics.Patient required repeated wound care changes.The mesh was surgically removed.Abscesses had formed in patients abdominal cavity.The surgeon reported that the mesh was not the source of the infection, but post-surgical noncompliance.The patient has alleged permanent mental and physical pain, permanent injuries including abdominal pain and swelling has undergone and will under go corrective surgeries.

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 ventral hernia.It was reported that after implant, the patient experienced readmission to hospital with purulent damage (malodorous drainage) from the incision site and fatigue/generalized weakness.The mesh had become infected and peeled off the abdominal wall.The patient experienced abdominal wall abscess, anemia, unspecified type and elevated lfts, debilitating pain, non-healing wound, wound dehiscence of hernia incisional site, cellulitis, epigastric pain, shortness of breath, acute chest pain, gastritis, paraesophageal hiatal hernia, nausea, vomiting, and diarrhea.The patient was started on iv antibiotics, cultures revealed (b)(6) sensitive to clindamycin.Post-operative patient treatment included additional surgery including removal of infected abdominal wall mesh, placement of a wound vac, wound exploration, debridement of bone and wound vac placement, and skilled nursing home health visits.

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 ventral hernia.It was reported that after implant, the patient experienced readmission to hospital with purulent damage (malodorous drainage) from the incision site and fatigue/generalized weakness.The mesh had become infected and peeled off the abdominal wall.The patient experienced abdominal wall abscess, anemia, unspecified type and elevated lfts, debilitating pain, non-healing wound, wound dehiscence of hernia incisional site, cellulitis, epigastric pain, shortness of breath, acute chest pain, gastritis, paraesophageal hiatal hernia, nausea, vomiting, and diarrhea.The patient was started on iv antibiotics, cultures revealed (b)(6) sensitive to clindamycin.Post-operative patient treatment included additional surgery including removal of infected abdominal wall mesh, placement of a wound vac, wound exploration, debridement of bone and wound vac placement, and skilled nursing home health visits.

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 ventral hernia.It was reported that after implant, the patient experienced readmission to hospital with purulent damage (malodorous drainage) from the incision site and fatigue/generalized weakness.The mesh had become infected and peeled off the abdominal wall.The patient experienced abdominal wall abscess, anemia, unspecified type and elevated lfts, debilitating pain, non-healing wound, wound dehiscence of hernia incisional site, cellulitis, epigastric pain, shortness of breath, acute chest pain, gastritis, paraesophageal hiatal hernia, nausea, vomiting, and diarrhea.The patient was started on iv antibiotics, cultures revealed (b)(6) sensitive to clindamycin.Post-operative patient treatment included additional surgery including removal of infected abdominal wall mesh, placement of a wound vac, wound exploration, debridement of bone and wound vac placement, and skilled nursing home health visits.

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 a ventral hernia.It was reported that after implant, the patient experienced purulent malodorous drainage from a reddened incision site, wound dehiscence of hernia incisional site, mesh peeled off the abdominal wall, paraesophageal hiatal hernia, dizziness, fatigue, weakness, mesh mrsa infection, abdominal wall abscess, anemia, elevated lfts, debilitating pain, epigastric pain, acute chest pain, diverticulosis, adenoma, body aches, chills, non-healing wound, cellulitis, shortness of breath, gastritis, bowel obstruction, abdominal pain, nausea, vomiting, and diarrhea.Post-operative patient treatment included readmission to the hospital, iv antibiotics, removal of infected abdominal wall mesh, additional surgery, placement of a wound vac, wound exploration, and debridement.

• Brand Name: MESH SOFRADIM - PARIETEX¿ PROGRIP¿
• 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: tracy landers ; 5920 longbow drive; boulder,co, CT 80301 ; 3035816943
• MDR Report Key: 6983463
• MDR Text Key: 90422769
• Report Number: 9615742-2017-05575
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081050
• 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: 02/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Model Number: TEM2015G
• Device Catalogue Number: TEM2015G
• Device Lot Number: SPK0836X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/07/2022
• Date Device Manufactured: 12/09/2015
• 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): Required Intervention; Other
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 71 KG
• Patient Race: White