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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 TECR1515
Device Problems Contamination /Decontamination Problem (2895); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Adhesion(s) (1695); Purulent Discharge (1812); Unspecified Infection (1930); Inflammation (1932); Scarring (2061); Skin Discoloration (2074); Ulceration (2116); Hernia (2240); Injury (2348); Fibrosis (3167); No Code Available (3191)
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 a hernia. After treatment, the patient experienced removal of mesh due to mesh infection; chronic draining sinus tract; abdominal wall reconstruction; small bowel adhesions.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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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
lisa hernandez
60 middletown ave
north haven, CT 06473
2034925563
MDR Report Key7757869
MDR Text Key116269360
Report Number9615742-2018-01830
Device Sequence Number1
Product Code FTL
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
Type of Report Initial,Followup,Followup
Report Date 12/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/30/2019
Device Model NumberTECR1515
Device Catalogue NumberTECR1515
Device Lot NumberSOK0369X
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/04/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/04/2014
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: 08/07/2018 Patient Sequence Number: 1
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