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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 PPC2520
Device Problems Degraded (1153); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Wound Dehiscence (1154); Adhesion(s) (1695); Emotional Changes (1831); Failure of Implant (1924); Pain (1994); Scar Tissue (2060); Hernia (2240); Deformity/ Disfigurement (2360); Unspecified Tissue Injury (4559)
Event Type  Injury  
Manufacturer Narrative
Ppc12 parietene comp pp 12cm cir w thr (lot # pjc00107). 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 implant, the patient experienced broken down mesh, failure of mesh, defective mesh, adhesions, hernia recurrence, wound dehiscence, pain, scarring, disfigurement, psychological and emotional injuries, loss of enjoyment of life, disability, and loss of mental and emotional health. Post-operative patient treatment included revision surgery.
 
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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
tracy landers
5920 longbow drive
boulder, CO 80301
3035816943
MDR Report Key12345015
MDR Text Key267353389
Report Number9615742-2021-02053
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 08/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPPC2520
Device Catalogue NumberPPC2520
Device Lot NumberPJD00638
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/03/2021
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: 08/19/2021 Patient Sequence Number: 1
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