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U.S. Department of Health and Human Services

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

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SOFRADIM PRODUCTION SAS MESH SOFRADIM- PARIETEX COMPOSITE MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number PCO1510
Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Purulent Discharge (1812); Fistula (1862); Unspecified Infection (1930); Pain (1994); Scar Tissue (2060); Hernia (2240); Ascites (2596); Unspecified Tissue Injury (4559)
Event Type  Injury  
Manufacturer Narrative
Concomitant product: tecr1510 parietex rigid py 15x10cm x1, (lot # kh00032). 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 inguinal hernia. It was reported that after implant, the patient experienced pain, hernia recurrence, and infection. Post-operative patient treatment included revision surgery and wound vac placement.
 
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Brand NameMESH SOFRADIM- PARIETEX COMPOSITE MESH
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 Key12650560
MDR Text Key277108888
Report Number9615742-2021-02312
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,Followup,Followup
Report Date 11/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2015
Device Model NumberPCO1510
Device Catalogue NumberPCO1510
Device Lot NumberPIK00607
Was Device Available for Evaluation? No
Date Manufacturer Received11/10/2021
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: 10/18/2021 Patient Sequence Number: 1
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