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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 TCM4530
Medical Device Problem Codes Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Pain (1994); Hernia (2240); Discomfort (2330); Abdominal Distention (2601); Unspecified Tissue Injury (4559)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Concomitant medical product: surgimend mesh 16x20 cm (product id: unknown, lot number: 1606042).If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of an incisional hernia.It was reported that after implant, the patient experienced recurrence, disruption mesh, chronic pain, bulge, and discomfort.Post-operative patient treatment included hernia repair with new mesh and mesh re-secured.
 
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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 Key11090218
Report Number9615742-2020-02943
Device Sequence Number11652856
Product Code FTL
UDI-Device Identifier10884521178939
UDI-Public10884521178939
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
PMA/510(K) Number
K090858
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source consumer
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 12/29/2020
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 Date11/30/2019
Device Model NumberTCM4530
Device Catalogue NumberTCM4530
Device Lot NumberSOK0472X
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/02/2020
Initial Report FDA Received Date12/29/2020
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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