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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 LPG1510
Device Problems Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Emotional Changes (1831); Foreign Body Reaction (1868); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Scar Tissue (2060); Hernia (2240); Discomfort (2330); Impaired Healing (2378); Fluid Discharge (2686); Fibrosis (3167); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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 an umbilical hernia. It was reported that after implant, the patient experienced infection, recurrence, open draining wound, fibrosis, inflammation, multiple complex fascial defects, sinus tract, foreign body giant cell reaction, and abscess. Post-operative patient treatment included an umbilicus that was incised, revision surgery, and mesh removal.
 
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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 Key11090635
MDR Text Key224251041
Report Number9615742-2020-02952
Device Sequence Number1
Product Code FTL
UDI-Device Identifier10884521513136
UDI-Public10884521513136
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K120897
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,Followup
Report Date 04/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberLPG1510
Device Catalogue NumberLPG1510
Was Device Available for Evaluation? No
Date Manufacturer Received04/06/2022
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: 12/29/2020 Patient Sequence Number: 1
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