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

Model Number UNKNOWN PARIETEX

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Torn Material (3024); Material Split, Cut or Torn (4008)

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Failure of Implant (1924); Unspecified Infection (1930); Inflammation (1932); Nausea (1970); Necrosis (1971); Pain (1994); Tissue Damage (2104); Vomiting (2144); Chills (2191); Hernia (2240); Discomfort (2330); Injury (2348); Weight Changes (2607); No Code Available (3191)

Event Date 03/17/2017

Event Type  Injury  

Manufacturer Narrative

Manufacturer reference number: (b)(4).Patient information not provided.Lot number not provided.Udi not provided.Re-processing information not provided.Since the lot number was not provided, this information cannot be determined.(b)(4).

Event Description

The patient's attorney alleged a deficiency against the device resulting in an unspecified adverse outcome.Product was used for therapeutic treatment.A mesh device that was implanted in the patient's abdomen ripped apart.The patient suffered life-threatening complications from the structural failure of the implant and approximately ten centimeters of the patient's small intestine needed to be surgically removed.The patient is now in constant pain and has suffered a permanent reduction in her quality of life.

Manufacturer Narrative

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

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Per additional information received, surgery performed to repair recurrent hernia.Adhesions were found from mesh to loops of small intestines.They attempted to remove the remainder of the mesh, but were unable to do so without causing extensive damage to intestines.

Manufacturer Narrative

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

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.Product was used for therapeutic treatment of a hernia.After implant, it was reported that the patient experienced suffered life-threatening complications from the structural failure of the implant and approximately ten centimeters of the patient's small intestine needed to be surgically removed.The patient also experienced pain, abdominal wall discomfort, abdominal pain, bouts of emesis, chills, weight gain, incarcerated hernia, bulge, inability to eat due to nausea, soft mass palpated which cannot be fully reduced, diastasis, multiple ventral hernias, and torn mesh.The patient required additional surgery (b)(6) 2017 to repair the recurrent hernia.During the repair dense adhesions of bowel/omentum to the underside of the hernia sac mesh were found, where several loops of small bowel were incarcerated.Because of the large hernia and prior resection of mesh/rectus muscle, there was a loss of abdominal domain.Mesh removal was attempted but could not be completed without causing extensive damage to intestines.

• 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: lisa hernandez ; 60 middletown ave; north haven, CT 06473 ; 2034925563
• MDR Report Key: 6610584
• MDR Text Key: 76639535
• Report Number: 9615742-2017-05152
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN PARIETEX
• Device Catalogue Number: UNKNOWN PARIETEX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/05/2018
• Was Device Evaluated by Manufacturer?: No
• 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): Hospitalization; Life Threatening; Other; Required Intervention
• Patient Age: 30 YR
• Patient Weight: 83