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U.S. Department of Health and Human Services

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

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SOFRADIM PRODUCTION SAS PARIETEX MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number PCO2015OSX
Device Problems Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bacterial Infection (1735); Purulent Discharge (1812); Emotional Changes (1831); Unspecified Infection (1930); Pain (1994); Staphylococcus Aureus (2058); Discharge (2225); Hernia (2240); Injury (2348); Impaired Healing (2378); Fluid Discharge (2686); 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 a hernia. It was reported that after implant, the patient experienced chronic pain, non-healing superficial wound, and infection. Post-operative patient treatment included revision and removal surgery.
 
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 a ventral incisional hernia. It was reported that after implant, the patient experienced recurrence, chronic draining abdominal wound, non-healing superficial wound, staphylococcus aureus, purulent material, mental pain, pain, disability, impairment, loss of enjoyment of life, defective mesh, and infection. Post-operative patient treatment included revision surgery, wound vac, excision of chronic draining wound, antibiotics, component separation, and removal surgery.
 
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 ventral incisional hernia. It was reported that after implant, the patient experienced recurrence, chronic pain, chronic draining abdominal wound, non-healing superficial wound, staphylococcus aureus, purulent material, and infection. Post-operative patient treatment included revision surgery, wound vac, excision of chronic draining wound, antibiotics, component separation, and removal surgery.
 
Event Description
The patient¿s attorney alleged a deficiency against the device. The product was used for therapeutic treatment of a ventral incisional hernia. It was reported that after implant, the patient experienced recurrence, chronic pain, chronic draining abdominal wound, non-healing superficial wound, and infection. Post-operative patient treatment included revision surgery, wound vac, excision of chronic draining wound, and removal surgery.
 
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. (b)(4). If information is provided in the future, a supplemental report will be issued.
 
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Brand NamePARIETEX
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 Key8174762
MDR Text Key130676657
Report Number9615742-2018-02815
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110816
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Non-Healthcare Professional
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 Received12/18/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/10/2014
Device Model NumberPCO2015OSX
Device Catalogue NumberPCO2015OSX
Device Lot NumberPMJ00636
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: 12/18/2018 Patient Sequence Number: 1
Treatment
UNKABSTACK(LOT#: UNKNOWN)
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