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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 Material Erosion (1214); Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Abscess (1690); Erosion (1750); Unspecified Infection (1930); Internal Organ Perforation (1987); Pain (1994); Discharge (2225); Injury (2348); Fluid Discharge (2686); No Code Available (3191); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative
This information was received as a part of an extensive mesh litigation submission to medtronic. The fda was notified of this large complaint receipt. Due to the volume of complaint information received by medtronic, this resulted in a report beyond the 30 day target. 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 a laparoscopic incisional hernia. It was reported that after the implant, the patient experienced pain, erosion, organ perforation, abscess, draining sinus tract, loose portion of mesh, and infection. Post-operative patient treatment included revision surgery and excision of loose portion of mesh.
 
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 preoperative and postoperative diagnosis was incisional hernia. The procedure performed was a laparoscopic incisional hernia repair with mesh. The patient experienced surgical revision, pain, erosion, organ perforation and infections.
 
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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 Key7036680
MDR Text Key252742100
Report Number9615742-2017-05767
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 Other,Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date 12/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/16/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2012
Device Model NumberPCO12
Device Catalogue NumberPCO12
Device Lot NumberPHI00459
Was Device Available for Evaluation? No
Date Manufacturer Received11/17/2021
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: 11/16/2017 Patient Sequence Number: 1
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