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); Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Pain (1994); Seroma (2069); Post Operative Wound Infection (2446)

Event Date 07/29/2016

Event Type  Injury  

Manufacturer Narrative

Title: the transinguinal preperitoneal technique (tipp) in inguinal hernia repair does not cause less chronic pain in relation to the progrip technique: a prospective double-blind randomized clinical trial comparing the tipp technique, using the polysoft mesh, with the progrip self-fixing semi-resorbable mesh source: hernia.2017 feb;21(1):17-27.Doi 10.1007/s10029-016-1522-6.Epub 2016 aug 18.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature source of study, the surgeons compared the repair of primary unilateral inguinal hernia with the reported polyester mesh in the lichtenstein-like repair vs.Polypropylene mesh from another brand in the transinguinal preperitoneal in a randomized, double-blind controlled trial.Two weeks postoperatively, patients complained of postoperative hematomas, hypersensitivity, and scrotal pain.According to patients at two weeks in the polyester mesh group, complications include seven seromas, ten bleedings, five wound infections, 23 hypersensitivities, 21 scrotal pain, one testicular atrophy, and six others.After one year, complications according to patients at one year in the polyester mesh group include (0 seroma, 0 bleeding, one wound infection, two hypersensitivity, two scrotal pain, 0 testicular atrophy, and six others.) three patients developed a recurrence.All recurrences were identified during a physical examination by the physician in the outpatient clinic and, in some cases, confirmed with an ultrasound.Only one of these three polyester mesh patients with a recurrence has been reoperated and turned out to have a medial recurrence.

• 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: 12061293
• MDR Text Key: 258162832
• Report Number: 9615742-2021-01553
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2021
• 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: 06/03/2021
• 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
• Patient Age: 58 YR