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U.S. Department of Health and Human Services

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

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SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX¿ PROGRIP¿ MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number TEM1208GL
Device Problems Material Perforation (2205); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Purulent Discharge (1812); Internal Organ Perforation (1987); Pain (1994); Perforation (2001); Hernia (2240); Injury (2348); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
(b)(4). 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 underwent a repair of bilateral inguinal hernias, right both indirect and direct, and left a direct. The left side was done with mesh, the right side was not. He had revision surgery 2 years and 1 month post-surgery. The patient experienced surgical revision, recurrence repair, pain, and organ perforation.
 
Event Description
The patient¿s attorney alleged a deficiency against the device. The product was used for therapeutic treatment of bilateral inguinal hernia. It was reported that after implant, the patient experienced recurrence, pain, and organ perforation. Post-operative patient treatment included revision surgery and recurrence repair.
 
Manufacturer Narrative
This information was received as a part of an extensive mesh litigation submission to medtronic. The fda was notified of this large complaint receipt. Due to the volume of complaint information received by medtronic, this resulted in a report beyond the 30 day target. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameMESH SOFRADIM - PARIETEX¿ PROGRIP¿
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
SOFRADIM PRODUCTION SAS
116 avenue du formans
trevoux 01600
FR 01600
MDR Report Key7448417
MDR Text Key106134263
Report Number9615742-2018-00929
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
K081050
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup,Followup
Report Date 01/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/20/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2018
Device Model NumberTEM1208GL
Device Catalogue NumberTEM1208GL
Device Lot NumberSNJ1012
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/22/2019
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 04/20/2018 Patient Sequence Number: 1
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