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

Model Number PCO2015X

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

Patient Problems Wound Dehiscence (1154); Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Bacterial Infection (1735); Purulent Discharge (1812); Fever (1858); Fistula (1862); Unspecified Infection (1930); Itching Sensation (1943); Nausea (1970); Pain (1994); Rash (2033); Seroma (2069); Urinary Tract Infection (2120); Vomiting (2144); Discharge (2225); Hernia (2240); Discomfort (2330); Injury (2348); Impaired Healing (2378); Obstruction/Occlusion (2422); Ascites (2596); Blood Loss (2597); Dysuria (2684); Fluid Discharge (2686); 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 an incisional hernia. It was reported that after implant, the patient experienced adhesions, bowel obstruction, infection, recurrent incisional hernia, vomiting green emesis, abdominal pain, uti, right lower back and lower abdominal pain, right flank pain, kidney stones, urine culture + for e. Coli, nausea, lysis of adhesions, dilated small bowel with omentum adhered to the anterior abdominal wall, one thick adhesive band to small bowel mesentery leading to obstruction, severe epigastric pain, seroma, fever, abscess, pus lying on mesh, wound remains open (home healthcare visits for dressing changes/wound care), granulation tissue, itchy mild rash around wound, painful urination (diagnosed with dysuria), and mucus type green drainage. Post-operative patient treatment included revision and removal surgery.

• 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: 8455860
• MDR Text Key: 139995304
• Report Number: 9615742-2019-00712
• Device Sequence Number: 1
• Product Code: FTL
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 03/31/2015
• Device Model Number: PCO2015X
• Device Catalogue Number: PCO2015X
• Device Lot Number: PND0323
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/16/2020
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 03/27/2019 Patient Sequence Number: 1