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 Hematoma (1884); Unspecified Infection (1930); Pain (1994); Seroma (2069); Post Operative Wound Infection (2446)

Event Date 05/08/2021

Event Type  Injury  

Event Description

According to the literature, a retrospective study analyzed outcomes of patients who underwent robotic-assisted abdominal wall repair between july 2016 and march 2020.There were 312 patients in the study of which 174 were inguinal hernia repairs, and 138 were abdominal wall hernia repairs.A self-fixating mesh was used in 92 patients, a three-dimensional monofilament polyester was used in 56, a transparent macroporous polypropylene composite was used in 3.Postoperative complications included: seroma, infection, hematoma, uncontrolled pain.Readmission was required for pain control and wound infection while seromas did not require treatment.

Manufacturer Narrative

Title: robotic abdominal wall repair: adoption and early outcomes in a large academic medical center source: journal of robotic surgery (2022) 16:383¿392.Https://doi.Org/10.1007/s11701-021-01251-2.If information is provided in the future, a supplemental report will be issued.

• 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: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 14552759
• MDR Text Key: 293078147
• Report Number: 9615742-2022-00486
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2022
• 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
• Date Manufacturer Received: 05/16/2022
• 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