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

Model Number UNKNOWN PROGRIP MESH PRODUCT

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

Patient Problems Unspecified Infection (1930); Pain (1994); Sepsis (2067); Urinary Retention (2119); Hematuria (2558); Radiation Exposure, Unintended (3164); No Code Available (3191)

Event Date 09/01/2015

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the reporter, two weeks after mesh placement, the patient went back to the hospital for severe bladder infection and sepsis.Patient was released three days after from the hospital, but the sepsis never went away after antibiotics.Patient went back to the hospital due to sepsis.Patient reported keep having pain, infection and burning, which took him back to the emergency room (er).Patient was told by his neurologist he would be on permanent disability for two-fold surgical and neurological.Patient reported still having problems with the mesh to date.Patient had been to the er many times because of chronic pain, urinating blood, and urinary retention.Patient also reported having many procedures; ct scan, mri, 7 surgical right inguinal nerve blocks, ultrasound and was on many medications.

• Brand Name: UNKNOWN PROGRIP MESH PRODUCT
• 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: 9793002
• MDR Text Key: 182162804
• Report Number: 9615742-2020-00551
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,user facility
• Type of Report: Initial
• Report Date: 03/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 02/19/2020
• Initial Date FDA Received: 03/05/2020
• 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; Required Intervention