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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS PROGRIP
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SOFRADIM PRODUCTION SAS PROGRIP Back to Search Results
Model Number UNKNOWN PROGRIP MESH PRODUCT
Device Problems Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problems Abscess (1690); Adhesion(s) (1695); Emotional Changes (1831); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Scar Tissue (2060); Hernia (2240); Unspecified Tissue Injury (4559)
Event Type  Injury  
Manufacturer Narrative
Concomitant product: unknown symbotex mesh (lot # unknown). Medtronic is submitting 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 implant, the patient experienced an infected mesh and abscess.
 
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Brand NamePROGRIP
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 80301
3035816943
MDR Report Key12651550
MDR Text Key277100145
Report Number9615742-2021-02319
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNKNOWN PROGRIP MESH PRODUCT
Device Catalogue NumberUNKNOWN PROGRIP MESH PRODUCT
Was Device Available for Evaluation? No
Date Manufacturer Received02/09/2022
Was Device Evaluated by Manufacturer? No Answer Provided
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: 10/18/2021 Patient Sequence Number: 1
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