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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 LPG1612AR
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Pain (1994)
Date of Event 01/13/2021
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, four months following a laparoscopic right inguinal hernia repair with mesh, the patient experienced constant pain on the groin, leg and lower abdomen.It was stated that the patient struggled with constant nagging pain and burning sensation and could not sit comfortably.The patient can only sleep on one side and had disrupted sleep several times every night causing the patient to be tired and lethargic during the day.
 
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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 Key11913912
Report Number9615742-2021-01425
Device Sequence Number3399643
Product Code FTL
UDI-Device Identifier10884521513228
UDI-Public10884521513228
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
K143386
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source foreign
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 06/01/2021
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 NumberLPG1612AR
Device Catalogue NumberLPG1612AR
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/08/2021
Initial Report FDA Received Date06/01/2021
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 Other;
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