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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 UNKNOWN PARIETEX
Device Problems Material Erosion (1214); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Bacterial Infection (1735); Erosion (1750); Purulent Discharge (1812); Fistula (1862); Foreign Body Reaction (1868); Hematoma (1884); Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Scarring (2061); Discharge (2225); Hernia (2240); Injury (2348); Impaired Healing (2378); Fibrosis (3167); No Code Available (3191); Constipation (3274)
Event Type  Injury  
Manufacturer Narrative
(b)(4). 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 an incisional hernia. It was reported that after implant, the patient experienced recurrence, constipation, chronic infection, infected mesh, bacterial infection, erosion, severe dense adhesions, abscess cavities, abdominal pain, drainage, purulent fluid, peripancreatic phlegmon/mass, open wound, severe abdominal wall scarring, purulent liquified hematoma, large soft tissue mass, extensive fibrosis with focal fat necrosis, chronic inflammation, foreign body giant cell reaction, chronic draining sinus, and fistula. Post-operative patient treatment included revision surgery, exploratory laparotomy, debridement of peripancreatic phlegmon/mass, debridement and excision of infected abdominal wall, excision of chronic draining sinus, deserosalization, excisional biopsy of luq intra-abdominal soft tissue mass, extensive lysis of adhesions, wound vac, wound culture, gram stain, abscess was opened at the bedside, implant of new progrip mesh, and excision of infected mesh.
 
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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
lisa hernandez
60 middletown ave
north haven, CT 06473
2034925563
MDR Report Key8923662
MDR Text Key155954234
Report Number9615742-2019-02866
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
Report Date 08/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/22/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNKNOWN PARIETEX
Device Catalogue NumberUNKNOWN PARIETEX
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/31/2019
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: 08/22/2019 Patient Sequence Number: 1
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