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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 PCO12
Device Problems Migration or Expulsion of Device (1395); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Emotional Changes (1831); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Scar Tissue (2060); Scarring (2061); Injury (2348); Impaired Healing (2378); Fibrosis (3167); No Code Available (3191); Unspecified Tissue Injury (4559)
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 incarcerated ventral hernia. It was reported that after implant, the patient experienced infection, chronic non-healing wound, scarring, fibrosis, inflammation, and large wad of mesh with sutures largely unincorporated. Post-operative patient treatment included removal of mesh due to chronic mesh infection and chronic non-healing wound.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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 incarcerated ventral hernia. It was reported that after implant, the patient experienced infection, chronic non-healing wound, scarring, and large wad of mesh with sutures largely unincorporated. Post-operative patient treatment included removal of mesh due to chronic mesh infection and chronic non-healing wound.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The patient's attorney alleged a deficiency against the device resulting in an unspecified adverse outcome. Product was used for therapeutic treatment. The patient underwent a hernia repair with mesh. She had revision surgery 2 years post-surgery. The patient experienced removal of mesh due to chronic mesh infection and chronic non-healing wound.
 
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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, CT 80301
3035816943
MDR Report Key7140544
MDR Text Key247300325
Report Number9615742-2017-06148
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K040998
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Non-Healthcare Professional
Remedial Action Notification
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 02/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2015
Device Model NumberPCO12
Device Catalogue NumberPCO12
Device Lot NumberPKC00384
Was Device Available for Evaluation? No
Date Manufacturer Received01/26/2022
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: 12/21/2017 Patient Sequence Number: 1
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