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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 TEM3015G
Device Problems Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Adhesion(s) (1695); Emotional Changes (1831); Foreign Body Reaction (1868); Inflammation (1932); Necrosis (1971); Pain (1994); Scar Tissue (2060); Scarring (2061); Hernia (2240); Discomfort (2330); Injury (2348); Unspecified Tissue Injury (4559)
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
The patient¿s attorney alleged a deficiency against the device. The product was used for therapeutic treatment of a ventral incisional hernia. It was reported that after the implant, the patient experienced recurrence, scarring, necrosis, forgein body giant cell reaction, and adhesions. Post-operative patient treatment included revision surgery, removal of mesh, and component separation.
 
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Brand NamePROGRIP
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
SOFRADIM PRODUCTION SAS
116 avenue du formans
trevoux 01600
FR 01600
Manufacturer (Section G)
SOFRADIM PRODUCTION SAS
116 avenue du formans
trevoux 01600
FR 01600
Manufacturer Contact
tracy landers
5920 longbow drive
boulder,co, CT 80301
3035816943
MDR Report Key10557103
MDR Text Key207689313
Report Number9615742-2020-02051
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K081050
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 04/05/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/18/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberTEM3015G
Device Catalogue NumberTEM3015G
Device Lot NumberSSH0179X
Was Device Available for Evaluation? No
Date Manufacturer Received03/16/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/24/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/18/2020 Patient Sequence Number: 1
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