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U.S. Department of Health and Human Services

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

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SOFRADIM PRODUCTION SAS UNKNOWN PROGRIP MESH PRODUCT MESH, SURGICAL, POLYMERIC Back to Search Results
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.
 
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Brand NameUNKNOWN PROGRIP MESH PRODUCT
Type of DeviceMESH, 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 Key12061293
MDR Text Key258162832
Report Number9615742-2021-01553
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeNL
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation
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 Received06/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNKNOWN PROGRIP MESH PRODUCT
Device Catalogue NumberUNKNOWN PROGRIP MESH PRODUCT
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/03/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/24/2021 Patient Sequence Number: 1
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