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

Model Number TECT1510AR

Device Problems Migration or Expulsion of Device (1395); Product Quality Problem (1506); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Seroma (2069); Hernia (2240); Injury (2348); 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 a hernia.It was reported that after implant, the patient experienced hematoma, recurrent ventral incisional hernia repaired with new symbotex mesh, drainage of ascites, hematoma, left groin seroma, recurrence of left inguinal hernia repaired with progrip mesh, drainage of peritoneal fluid, inguinal bulging due to parietex mesh protrusion through the peritoneal cavity.Treatment provided for these conditions include removal and revision surgery.

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.Concomitant medical products: sym1510 stex 15x10 cm x1 (lot# unknown), abstack30 abs fixation device 30 tacks (lot# unknown).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 and bilateral inguinal hernia.It was reported that after implant, the patient experienced recurrence, peritoneal fluid, protrusion of corner of mesh, hematoma, seroma, and bulging.Post-operative patient treatment included revision surgery, repair of hernia with mesh, excision of mesh, drainage of peritoneal fluid, pushed old piece of mesh in and sewed it to inguinal ligament and cooper ligament.

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 incisional hernia and bilateral inguinal hernia.It was reported that after implant, the patient experienced recurrence, peritoneal fluid, protrusion of corner of mesh, hematoma, seroma, mesh migration, ascites, large loculated sac, and bulging.Post-operative patient treatment included revision surgery, repair of hernia with mesh, excision of mesh, drainage of peritoneal fluid, pico wound vac, pushed old piece of mesh in and sewed it to inguinal ligament and cooper ligament.

• Brand Name: PARIETEX
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• MDR Report Key: 8001959
• MDR Text Key: 124898770
• Report Number: 9615742-2018-02440
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K982532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 11/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TECT1510AR
• Device Catalogue Number: TECT1510AR
• 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
• Treatment: UNKNOWN PARIETEX PRODUCT (LOT# UNKNOWN)
• Patient Outcome(s): Required Intervention