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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS PARIETEX MESH, SURGICAL, POLYMERIC

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SOFRADIM PRODUCTION SAS PARIETEX MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number TECR1510
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Adhesion(s) (1695); Erosion (1750); Emotional Changes (1831); Fatigue (1849); Foreign Body Reaction (1868); Unspecified Infection (1930); Inflammation (1932); Internal Organ Perforation (1987); Pain (1994); Scar Tissue (2060); Urinary Retention (2119); Burning Sensation (2146); Hernia (2240); Injury (2348); Sleep Dysfunction (2517); No Code Available (3191); Unspecified Tissue Injury (4559)
Event Type  Injury  
Event Description
The patient's attorney alleged a deficiency against the device. Product was used for therapeutic treatment of an inguinal hernia. It was reported that after implant, the patient experienced adhesions, recurrence, infection, chronic pain, inflammation, scarification, mesh encapsulation, lack of adequate ingrowth, bladder perforation and mesh eroding into muscle wall of bladder. Post- operative treatment included removal or revision surgery resulting from complications from mesh, cystoscopy, right ureteroscopy, stone basketing, right ureteral balloon dilatation, fulguration and vaporization of median lobe left ureteral stenting, lysis of eroding mesh into the bladder, left ureteral stenting and closure of bladder perforation, fulguration and vaporization of median lobe.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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 resulting in an unspecified adverse outcome. Product was used for therapeutic treatment. The patient has had removal or revision surgery resulting from complications from mesh.
 
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Brand NamePARIETEX
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
justin ellis
5920 longbow drive
8200 coral sea st ne
mounds view,mn, CT 55112
7635265677
MDR Report Key7179656
MDR Text Key284138410
Report Number9615742-2018-00136
Device Sequence Number1
Product Code FTL
UDI-Device Identifier10884521180284
UDI-Public10884521180284
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K982532
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,Followup,Followup
Report Date 10/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/10/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2021
Device Model NumberTECR1510
Device Catalogue NumberTECR1510
Device Lot NumberSQE0171X
Was Device Available for Evaluation? No
Date Manufacturer Received10/05/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/24/2016
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: 01/10/2018 Patient Sequence Number: 1
Treatment
UNKNOWN TACKER
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