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U.S. Department of Health and Human Services

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

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SOFRADIM PRODUCTION SAS UNKNOWN PROGRIP MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number UNKNOWN PROGRIP MESH PRODUCT
Device Problem Material Split, Cut or Torn (4008)
Patient Problems Hematoma (1884); Irritation (1941); Pain (1994); Seroma (2069); Tissue Damage (2104); Hernia (2240); Post Operative Wound Infection (2446); Blood Loss (2597); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative

(b)(4). Title: lower incidence of postoperative pain after open inguinal hernia surgery with the usage of synthetic glue¿coated mesh: anna-maria tholix, md, december 2018, the american surgeon. If information is provided in the future, a supplemental report will be issued.

 
Event Description

According to literature source of study performed, the aim of the study was to compare two self-adhering meshes, to evaluate their impact on postoperative chronic pain and overall recovery. The study was to compare outpatient clinic readmissions due to postoperative pain after hernia surgery. There were 393 open inguinal hernia operations sorted into two groups, one group was 169 and the other was 224. Post-operatively on the other mesh group, two patients had pain for over one year. One patient had 17 visits to the outpatient clinic because of chronic postoperative pain and a postoperative seroma. The patient had a scrotal hernia and developed a chronic scrotal seroma postoperatively, which was treated operatively six months after the primary operation. The patient also had chronic groin pain for 2. 5 years after the operation. Eight patients required anti-inflammatory drugs or paracetamol for pain, 6 patients were given a corticosteroid injection and a long lasting anesthetic, and 3 patients needed neuropathic pain medication. Additional post-operative complications reported include: wound hematoma or bleeding = 4, superficial wound infection = 2, deep wound infection = 1, and seroma = 2. One explanation for the difference in pain between the two meshes might be that the barbs in the anchoring system in the mesh are traumatic and tear on the underlying tissue and nerves causing micro-bleeding and irritation.

 
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Brand NameUNKNOWN PROGRIP
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
lisa hernandez
60 middletown ave.
north haven, CT 06473
2034925563
MDR Report Key8445584
MDR Text Key139672025
Report Number9615742-2019-00619
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeFI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,L
Reporter Occupation
Type of Report Initial
Report Date 03/22/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/22/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberUNKNOWN PROGRIP MESH PRODUCT
Device Catalogue NumberUNKNOWN PROGRIP MESH PRODUCT
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/27/2019
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: 03/22/2019 Patient Sequence Number: 1
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