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

Model Number SPM-35

Device Problems Degraded (1153); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Unspecified Infection (1930); Hernia (2240); Impaired Healing (2378); Obstruction/Occlusion (2422); Ascites (2596); Fluid Discharge (2686); Unspecified Tissue Injury (4559)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 8cm/3.2" davol inc- mesh large circle with strap, product id: 5950009, lot # huar1431, exp.Date 05-28-2018.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 a ventral hernia.It was reported that after the overlay implant, the patient experienced abdominal wound fluid collection, infection, thick mesh, incarcerated small bowel, adhesions, serous fluid, midline defect, bowel obstruction, and recurrence.Post-operative patient treatment included drainage of abdominal wound fluid collection, removal of mesh, wound vac, wound vac removed, lysis of adhesions, enterolysis to reduce small bowel, drainage of serous fluid, right and left anterior component separation, and hernia repair with new mesh.

• Brand Name: SURGIPRO
• 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: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 12025481
• MDR Text Key: 257142901
• Report Number: 9615742-2021-01475
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521101364
• UDI-Public: 10884521101364
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K915526
• 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
• Report Date: 06/18/2021

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 Expiration Date: 02/28/2020
• Device Model Number: SPM-35
• Device Catalogue Number: SPM-35
• Device Lot Number: A5B0864X
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/02/2021
• Initial Date FDA Received: 06/18/2021
• Date Device Manufactured: 02/19/2015
• 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
• Patient Weight: 113