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

Model Number PCO2015

Device Problems Loss of or Failure to Bond (1068); Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993); Material Split, Cut or Torn (4008)

Patient Problems Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Anemia (1706); Cellulitis (1768); Dysphagia/ Odynophagia (1815); Edema (1820); Erythema (1840); Fever (1858); Foreign Body Reaction (1868); Pyrosis/Heartburn (1883); Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Pain (1994); Staphylococcus Aureus (2058); Seroma (2069); Swelling (2091); Burning Sensation (2146); Discharge (2225); Hernia (2240); Injury (2348); Ascites (2596); Abdominal Distention (2601); Weight Changes (2607); Fibrosis (3167); 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 infection, recurrence, and adhesions. Post-operative patient treatment included multiple surgical revisions.

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 laparoscopic therapeutic treatment of a recurrent incisional hernia. It was reported that after implant, the patient experienced infection, recurrence, adhesions, gerd, weight gain, poor esophageal function, pain, mesh pulled away, bulge, heartburn, neck burning sensation, mesh pulled apart, anemia, abdominal pain, erythema, edema, cellulitis, phlegmon, serosanguinous fluid, seroma, encapsulated mesh, abscess, necrotic fat, swelling, fevers, enlarged liver, fluid behind the mesh with air bubbles in it, staphylococcus aureus, chronic inflammation, foreign body giant cell reaction, fluid collection, fibrosis, tortuous esophagus, and dysphagia. Post-operative patient treatment included multiple surgical revisions, redo nissen fundoplication, peg tube insertion 20-french, picc line placed for iv antibiotics, wound vac, hospitalized, oral antibiotics, pain medication, component separation bilaterally with lateral release, debridement, drainage of abscess, endoscopy with manometry catheter placement, and an esophagogastroscopy.

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 a recurrent incisional hernia. It was reported that after implant, the patient experienced infection, recurrence, mesh pulled out on left side but not right, and adhesions. Post-operative patient treatment included multiple surgical revisions.

• Brand Name: MESH SOFRADIM - PARIETEX¿ OPTIMIZED COMPOSITE MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• MDR Report Key: 8188470
• MDR Text Key: 131128955
• Report Number: 9615742-2018-02884
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K110815
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 10/31/2013
• Device Model Number: PCO2015
• Device Catalogue Number: PCO2015
• Device Lot Number: PIK00611
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 12/21/2018 Patient Sequence Number: 1