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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 TEM1409GR
Device Problems Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Abscess (1690); Emotional Changes (1831); Unspecified Infection (1930); Inflammation (1932); Nerve Damage (1979); Pain (1994); Scar Tissue (2060); 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 hernia. The product was used for therapeutic treatment of abdominal pain, abscess, scarring, infection, nerve damage, inflammation, pain, disability, loss of enjoyment of life, impairment, defective mesh, and mental pain. Post-operative patient treatment included revision surgery, removal of mesh.
 
Manufacturer Narrative
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 Key13620006
MDR Text Key286249400
Report Number9615742-2022-00147
Device Sequence Number1
Product Code FTL
UDI-Device Identifier10884521177710
UDI-Public10884521177710
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
Report Date 02/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/28/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2021
Device Model NumberTEM1409GR
Device Catalogue NumberTEM1409GR
Device Lot NumberSQE0212X
Was Device Available for Evaluation? No
Date Manufacturer Received02/09/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/01/2016
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: 02/28/2022 Patient Sequence Number: 1
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