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

Model Number PCO8VP

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

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Foreign Body Reaction (1868); Nausea (1970); Pain (1994); Vomiting (2144); Hernia (2240); Injury (2348); Obstruction/Occlusion (2422); Foreign Body In Patient (2687); 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 resulting in an unspecified adverse outcome.Product was used for therapeutic treatment.The patient underwent an umbilical hernia repair.He had revision surgery 2 years and 9 months post-operative.At this time the patient underwent a robotic-assisted laparoscopic lysis of adhesions due to small bowel obstruction.The patient experienced multiple surgical revisions, and pain.

Manufacturer Narrative

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

Event Description

Per additional information received the patient experienced patient developed nausea and vomiting.

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 umbilical hernia.It was reported that after implant, the patient experienced recurrence, nausea, vomiting, abdominal pain, adhesions, mesh pulled away from abdominal wall, and small bowel obstruction.Post-operative patient treatment included revision surgery, robotic-assisted laparoscopic lysis of adhesions, and mesh reattached using tacks.

• 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
• Manufacturer (Section G): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• Manufacturer Contact: lisa hernandez ; 60 middletown ave; north haven, CT 06473 ; 2034925563
• MDR Report Key: 7135219
• MDR Text Key: 95396687
• Report Number: 9615742-2017-06173
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521165724
• UDI-Public: 10884521165724
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120506
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup,Followup
• Report Date: 10/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2015
• Device Model Number: PCO8VP
• Device Catalogue Number: PCO8VP
• Device Lot Number: PMK00532
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/15/2019
• 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): Other; Required Intervention
• Patient Age: 54 YR
• Patient Weight: 133