MAUDE Adverse Event Report: TISSUE SCIENCE LABORATORIES PERMACOL; MESH, SURGICAL

Model Number P151015

Device Problems Product Quality Problem (1506); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993); Material Split, Cut or Torn (4008)

Patient Problems Abscess (1690); Adhesion(s) (1695); Cellulitis (1768); Purulent Discharge (1812); Fistula (1862); Unspecified Infection (1930); Nausea (1970); Pain (1994); Discharge (2225); Hernia (2240); Injury (2348); Impaired Healing (2378); Ascites (2596); Abdominal Distention (2601); No Code Available (3191)

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 umbilical hernia.It was reported that after implant, the patient experienced recurrence, chronic non-healing draining abdominal wound, deep subcutaneous abscess pockets with purulent fluid, drain clogged up and pocketed at this material in the subcutaneous position, whitish color of the porcine mesh, small flakes of the mesh coming off, infection, bulge in abdomen, pain, nausea, several loops of small bowel that stuck to the fascia and the previous mesh, and tight adhesions.Post-operative patient treatment included incision and drainage of abdominal wall abscess and wound debridement, placement of draining tube, recurrent incarcerated incisional hernia repair with mesh and excision of mesh.

Manufacturer Narrative

Device code provided.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

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.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 recurrence, chronic non-healing draining abdominal wound, deep subcutaneous abscess pockets with purulent fluid, drain clogged up and pocketed at this material in the subcutaneous position, whitish color of the porcine mesh, small flakes of the mesh coming off, infection, bulge in abdomen, pain, nausea, fistula, fluid collection, andtight adhesions.Post-operative patient treatment included incision and drainage of abdominal wall abscess and wound debridement, placement of draining tube, subcutaneous tissue cleaned, recurrent incarcerated incisional hernia repair with mesh, and excision of 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.Additional information: b5, b6, b7, g4, 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 a ventral hernia.It was reported that after implant, the patient experienced recurrence, chronic non-healing draining abdominal wound, wound with crepitance and fluctuance, deep subcutaneous abscess pockets with purulent fluid, drain clogged up and pocketed at this material in the subcutaneous position, whitish color of the porcine mesh, small flakes of the mesh coming off, infection, cellulitis, bulge in abdomen, pain, nausea, fistula, fluid collection, and tight adhesions.Post-operative patient treatment included incision and drainage of abdominal wall abscess and wound debridement, iv zosyn for over three months without improvement, placement of drainage tube, subcutaneous tissue cleaned, recurrent incarcerated incisional hernia repair with mesh, excision of mesh, transversus abdominis plane block.

• Brand Name: PERMACOL
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): TISSUE SCIENCE LABORATORIES; victoria house, victoria road; aldershot, hampshire GU11 1EJ; GB GU11 1EJ
• MDR Report Key: 8495189
• MDR Text Key: 141318572
• Report Number: 9617613-2019-00043
• Device Sequence Number: 1
• Product Code: FTM
• UDI-Device Identifier: 10884523000160
• UDI-Public: 10884523000160
• Combination Product (y/n): N
• PMA/PMN Number: K120605
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2012
• Device Model Number: P151015
• Device Catalogue Number: P151015
• Device Lot Number: 09B0108
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR
• Patient Weight: 122