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

Model Number PCO2015X

Device Problems Loss of or Failure to Bond (1068); Degraded (1153); Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993); Material Split, Cut or Torn (4008)

Patient Problems Abscess (1690); Adhesion(s) (1695); Dysphagia/ Odynophagia (1815); Pyrosis/Heartburn (1883); Unspecified Infection (1930); Pain (1994); Seroma (2069); Burning Sensation (2146); Hernia (2240); Injury (2348); Ascites (2596); Abdominal Distention (2601); Weight Changes (2607); No Code Available (3191); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

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.

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, abdominal fluid collection, tortuous esophagus, abscess, seroma and dysphagia.Post-operative patient treatment included multiple surgical revisions, redo nissen fundoplication, peg tube insertion 20-french, endoscopy with manometry catheter placement, egd, hernia repair with mesh and an esophagogastroscopy.

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 recurrent incisional hernia.It was reported that after implant, the patient experienced infection, recurrence, mesh pulled out on left side but not on right, 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.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.(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, abdominal fluid collection, tortuous esophagus, and dysphagia.Post-operative patient treatment included multiple surgical revisions, redo nissen fundoplication, peg tube insertion 20-french, endoscopy with manometry catheter placement, egd, and an esophagogastroscopy.

• Brand Name: PARIETEX
• 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 80301 ; 3035816943
• MDR Report Key: 8190547
• MDR Text Key: 131195381
• Report Number: 9615742-2018-02886
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521179769
• UDI-Public: 10884521179769
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110815
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/08/2022

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: 05/31/2014
• Device Model Number: PCO2015X
• Device Catalogue Number: PCO2015X
• Device Lot Number: PMF00052
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/28/2018
• Initial Date FDA Received: 12/21/2018
• Supplement Dates Manufacturer Received: 05/15/2019; 05/15/2019; 02/09/2022
• Supplement Dates FDA Received: 11/12/2019; 02/03/2020; 03/08/2022
• 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: PCO3020 COMP 3DPY 30X20 CM NO THR (LOT# PKF00059)
• Patient Outcome(s): Required Intervention
• Patient Sex: Female
• Patient Weight: 94 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White