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

Model Number TEM1509G

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pulmonary Embolism (1498); Angina (1710); Cellulitis (1768); Hematoma (1884); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Pneumonia (2011); Seroma (2069); Thrombosis (2100); Urinary Retention (2119); Hematuria (2558); Blood Loss (2597); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the survey performed there were several complications experienced by the customer when using 8 brands of the company's self gripping mesh, namely inflammation for 25 patients, mesh infection for 15 patients, seroma/hematoma for 12 patients and infection particularly; wound infection, abdominal wall cellulitis and urinary tract infection for 25 patients.There was also pre operative complications, visceral injury, hemorrhage and severe bleeding for 1 patient.The usual post operative complications, were, prolonged ileus, urinary retention, wound complications for 10 patients.Several genital complications were also reported namely; scrotal pain, scrotal swelling, testis discomfort, hydrocele, testis atrophy, orchitis for 15 patients.Other complications were trocar site hernia and incisional hernia for 7 patients, pneumonia, hematuria, deep vein thrombosis, pulmonary embolism and angina pectoris for 2, 15, 3, 2 and 1 patients respectively.However on the listed complications inflammation, genital complications and trocar site hernia and incisional hernia were primarily due to patient condition or procedure related based on the respondent.

• Brand Name: 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: 8947723
• MDR Text Key: 156112379
• Report Number: 9615742-2019-02931
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521177673
• UDI-Public: 10884521177673
• Combination Product (y/n): N
• PMA/PMN Number: K081050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2012
• Device Model Number: TEM1509G
• Device Catalogue Number: TEM1509G
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/07/2019
• 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