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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 TEM1208GL
Device Problems Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Adhesion(s) (1695); Purulent Discharge (1812); Emotional Changes (1831); Erythema (1840); Fatigue (1849); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Nausea (1970); Necrosis (1971); Pain (1994); Scar Tissue (2060); Unspecified Tissue Injury (4559); Decreased Appetite (4569); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant product: tem1208gr progrip rt tem/pla12x8 cm (lot#: snc0492). 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 bilateral inguinal hernias. It was reported that after implant, the patient experienced abscess, infection, nausea, loss of appetite, swelling, inflammation, tissue friable/induration, necrosis, scarring, fatigue, pain, erythematous, bloody purulent drainage, and suffering. Post-operative patient treatment included revision surgery, admission to hospital, antibiotics, incision/drainage of abscess, washout/primary tissue repair of defect, and removal of infected mesh.
 
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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 80301
3035816943
MDR Report Key12285028
MDR Text Key265364347
Report Number9615742-2021-01886
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
Type of Report Initial,Followup,Followup
Report Date 04/01/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/05/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2015
Device Model NumberTEM1208GL
Device Catalogue NumberTEM1208GL
Device Lot NumberSKB00581
Was Device Available for Evaluation? No
Date Manufacturer Received03/16/2022
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: 08/05/2021 Patient Sequence Number: 1
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