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 Cellulitis (1768); Hematoma (1884); Pain (1994); Seroma (2069)

Event Date 02/22/2021

Event Type  Injury  

Manufacturer Narrative

Title: robotic transabdominal preperitoneal repair of complex inguinal hernias source: international journal of abdominal wall and hernia surgery - volume 4, issue 1, january-march 2021 published: 22-02-2021.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature, (february 2013 and may 2020) this study aimed to assess a retrospective study evaluated outcomes of patients who underwent robotic transabdominal preperitoneal repair of complex inguinal hernia.The common 12 x16 progrip mesh used in the procedure.There were 88 patients with 110 hernias.Postoperative complications included seroma, hematoma, cellulitis and pain.Seromas required a procedural intervention for treatment.Robotic transabdominal preperitoneal repair of complex inguinal hernias | [downloaded free from http://www.Herniasurgeryjournal.Org on thursday, july 15, 2021, ip: 10.232.74.26] | © 2021 international journal of abdominal wall and hernia surgery | published by wolters kluwer - medknow | received: 14-08-2020; accepted: 07-09-2020; published: 22-02-2021.

• 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: 12274112
• MDR Text Key: 264957465
• Report Number: 9615742-2021-01874
• 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: 08/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2021
• 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: 07/15/2021
• 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