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

Model Number UNKNOWN PROGRIP MESH PRODUCT

Device Problem Material Split, Cut or Torn (4008)

Patient Problems Hematoma (1884); Irritation (1941); Pain (1994); Seroma (2069); Tissue Damage (2104); Hernia (2240); Post Operative Wound Infection (2446); Blood Loss (2597); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Title: lower incidence of postoperative pain after open inguinal hernia surgery with the usage of synthetic glue¿coated mesh: anna-maria tholix, md, december 2018, the american surgeon.If information is provided in the future, a supplemental report will be issued.

Event Description

According to literature source of study performed, the aim of the study was to compare two self-adhering meshes, to evaluate their impact on postoperative chronic pain and overall recovery.The study was to compare outpatient clinic readmissions due to postoperative pain after hernia surgery.There were 393 open inguinal hernia operations sorted into two groups, one group was 169 and the other was 224.Post-operatively on the other mesh group, two patients had pain for over one year.One patient had 17 visits to the outpatient clinic because of chronic postoperative pain and a postoperative seroma.The patient had a scrotal hernia and developed a chronic scrotal seroma postoperatively, which was treated operatively six months after the primary operation.The patient also had chronic groin pain for 2.5 years after the operation.Eight patients required anti-inflammatory drugs or paracetamol for pain, 6 patients were given a corticosteroid injection and a long lasting anesthetic, and 3 patients needed neuropathic pain medication.Additional post-operative complications reported include: wound hematoma or bleeding = 4, superficial wound infection = 2, deep wound infection = 1, and seroma = 2.One explanation for the difference in pain between the two meshes might be that the barbs in the anchoring system in the mesh are traumatic and tear on the underlying tissue and nerves causing micro-bleeding and irritation.

• Brand Name: UNKNOWN PROGRIP
• 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: 8445584
• MDR Text Key: 139672025
• Report Number: 9615742-2019-00619
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: FI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN PROGRIP MESH PRODUCT
• Device Catalogue Number: UNKNOWN PROGRIP MESH PRODUCT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2019
• 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): Required Intervention