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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS PROGRIP; MESH, SURGICAL, POLYMERIC
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SOFRADIM PRODUCTION SAS PROGRIP; MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number LPG1614
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Pain (1994); Unintended Radiation Exposure (4565)
Date of Event 07/28/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to the reporter, after fixing the hernia defect in a laparoscopic inguinal hernia repair, patient was complaining about the chronic pain where mesh was implanted.The patient is been sent to do scanning to locate the right reason for pain in inguinal area.
 
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Brand Name
PROGRIP
Common Device Name
MESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
SOFRADIM PRODUCTION SAS
116 avenue du formans
trevoux 01600
FR  01600
MDR Report Key12316115
Report Number9615742-2021-01907
Device Sequence Number19793068
Product Code FTL
UDI-Device Identifier10884521513242
UDI-Public10884521513242
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
K143386
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2021
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 08/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model NumberLPG1614
Device Catalogue NumberLPG1614
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/28/2021
Initial Report FDA Received Date08/12/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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