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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS PARIETENE DS; MESH, SURGICAL, POLYMERIC
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SOFRADIM PRODUCTION SAS PARIETENE DS; MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number PPDS15
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Abscess (1690)
Date of Event 03/18/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to the reporter, following ventral hernia repair, a superficial abdominal wall abscess was observed.This resulted to pati ent extended hospitalization.
 
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Brand Name
PARIETENE DS
Common Device Name
MESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
SOFRADIM PRODUCTION SAS
116 avenue du formans
trevoux 01600
FR  01600
MDR Report Key11273103
Report Number9615742-2021-00307
Device Sequence Number19702713
Product Code FTL
UDI-Device Identifier10884521553460
UDI-Public10884521553460
Combination Product (Y/N)N
Initial Reporter StateWI
Initial Reporter CountryUS
PMA/510(K) Number
K163212
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 02/03/2021
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 Expiration Date06/30/2019
Device Model NumberPPDS15
Device Catalogue NumberPPDS15
Device Lot NumberRSA0017X
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/12/2021
Initial Report FDA Received Date02/03/2021
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 Hospitalization;
Patient Age54 YR
Patient Weight100
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