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U.S. Department of Health and Human Services

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

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SOFRADIM PRODUCTION SAS PARIETENE DS; MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number PPDS12
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Failure of Implant (1924); Inflammation (1932); Pain (1994); Scar Tissue (2060); Hernia (2240); Unspecified Tissue Injury (4559)
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: lpg1510ar 10x15cm lp antmcl mesh rt (lot#unknown), lpg1510al 10x15cm lp antmcl mesh lt(lot# unknown), ppds1 510 mesh parietene ds 15x10cm x1(lot#unknown).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 laparoscopic therapeutic treatment of an inguinal hernia.It was reported that after the implant, the patient experienced hernia recurrence, failure of mesh, pain, scarring, and inflammation.Post-operative patient treatment included revision surgery and placement of additional mesh.
 
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Brand Name
PARIETENE DS
Type of Device
MESH, 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 Key12374423
MDR Text Key268365969
Report Number9615742-2021-02083
Device Sequence Number1
Product Code FTL
UDI-Device Identifier10884521553446
UDI-Public10884521553446
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K163212
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 08/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/31/2020
Device Model NumberPPDS12
Device Catalogue NumberPPDS12
Device Lot NumberETA2395X
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 08/11/2021
Initial Date FDA Received08/26/2021
Date Device Manufactured01/21/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age59 YR
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