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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 Foreign Body Sensation in Eye (1869); Pain (1994); Post Operative Wound Infection (2446); No Code Available (3191)
Event Date 03/18/2020
Event Type  Injury  
Manufacturer Narrative

Title: randomized trial comparing self-gripping mesh with polypropylene mesh in female lichtenstein hernioplasty source: the american surgeon february 2020 vol. 86. (b)(4). If information is provided in the future, a supplemental report will be issued.

 
Event Description

According to literature source of study performed between january 2014 and january 2017, comparing the outcomes of using self-gripping mesh with polypropylene mesh secured with sutures in female lichtenstein hernioplasty, 103 patients were included in this prospective study. There were 51 laparoscopic self-fixating mesh patients and on the sutured polypropylene mesh were 52 patients. Postoperative outcomes included chronic pain at three months on 8 patients, at one year on 7 patients, and three years on 5 patients. On the laparoscopic self-fixating mesh group the following were noted; one patient also suffered superficial wound infection and was treated with drainage and antibiotics, without removal of the mesh, and 14 patients from the same group of self fixating mesh also suffered foreign body feeling. Article: dianchen wang, 2017, scientific and technological development project of henan province in 2017 (number: 172102310274)/registration number: chictr1800017360 (http://www. Chictr. Org. Cn).

 
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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
lisa hernandez
60 middletown ave
north haven, CT 06473
2034925563
MDR Report Key10754005
MDR Text Key213618461
Report Number9615742-2020-02437
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeCH
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 10/29/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/29/2020
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 Received10/12/2020
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: 10/29/2020 Patient Sequence Number: 1
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