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U.S. Department of Health and Human Services

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

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SOFRADIM PRODUCTION SAS PARIETENE MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number PPM3030
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Purulent Discharge (1812); Granuloma (1876); Failure of Implant (1924); Unspecified Infection (1930); 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. The product was used for therapeutic treatment of an incisional hernia. It was reported that after the implant, the patient experienced recurrence, infection, sinus tract, purulent material, granuloma, and mesh failure. Post-operative patient treatment included revision surgery, excisional debridement of surgical site infection, removal of sutures, wound debridement, wound vac/dressings, and removal of mesh.
 
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Brand NamePARIETENE
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 Key9974150
MDR Text Key188092161
Report Number9615742-2020-00920
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K142091
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 04/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPPM3030
Device Catalogue NumberPPM3030
Device Lot NumberPPM3030
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/25/2020
Was Device Evaluated by Manufacturer? No Answer Provided
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: 04/17/2020 Patient Sequence Number: 1
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