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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS PARIETEX; MESH, SURGICAL, POLYMERIC
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SOFRADIM PRODUCTION SAS PARIETEX; MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number TECR1410DP2
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Pain (1994); Disability (2371)
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 following a right direct inguinal procedure the patient felt like there was razor blades in his groin and that the patient felt like a flammable liquid lit on fire.The patient currently spends the time bedridden and needs a cane to get around.
 
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Brand Name
PARIETEX
Common Device Name
MESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
SOFRADIM PRODUCTION SAS
116 avenue du formans
trevoux 01600
FR  01600
MDR Report Key8223972
Report Number9615742-2019-00015
Device Sequence Number197268
Product Code FTL
UDI-Device Identifier10884521180062
UDI-Public10884521180062
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
K982532
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional,u
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 01/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date11/30/2021
Device Model NumberTECR1410DP2
Device Catalogue NumberTECR1410DP2
Device Lot NumberSQL0175X
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/11/2018
Initial Report FDA Received Date01/07/2019
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 Disability;
Patient Age42 YR
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