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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 LPG1510X2
Device Problems Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Emotional Changes (1831); Pain (1994); Scar Tissue (2060); Deformity/ Disfigurement (2360); Unspecified Tissue Injury (4559)
Event Type  Injury  
Event Description
The patient¿s attorney alleged a deficiency against the device. The product was used for therapeutic treatment of a bilateral inguinal hernia by laparoscopic repair and an umbilical hernia by open repair. It was reported that after implant, the patient experienced chronic pain, abdominal pain, defective device, physical deformity, mental and physical pain, mesh failure, mental anguish, scarring, disfigurement, suffering, disability, impairment, and loss of enjoyment of life. Post-operative patient treatment included ilioinguinal neurectomy and revision surgery.
 
Manufacturer Narrative
Concomitant product: lpg1510x2 10x15 cm lp flatsheet mesh (lot# ppj1010x), lpg1510x2 10x15 cm lp flatsheet mesh (lot# ppj1010x). If information is provided in the future, a supplemental report will be issued.
 
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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 Key12923116
MDR Text Key281656128
Report Number9615742-2021-02445
Device Sequence Number1
Product Code FTL
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
Report Date 12/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/03/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2018
Device Model NumberLPG1510X2
Device Catalogue NumberLPG1510X2
Device Lot NumberPPJ1010X
Was Device Available for Evaluation? No
Date Manufacturer Received01/16/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/03/2015
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: 12/03/2021 Patient Sequence Number: 1
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