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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 TET3030
Device Problems Migration or Expulsion of Device (1395); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Abscess (1690); Adhesion(s) (1695); Erosion (1750); Purulent Discharge (1812); Fistula (1862); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Muscle Weakness (1967); Necrosis (1971); Pain (1994); Hernia (2240); Impaired Healing (2378); Ascites (2596); Fluid Discharge (2686); Foreign Body In Patient (2687); Cancer (3262); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: pco3020 comp 3dpy 30x20cm no thr (lot# b22148pco32) (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 a incisional hernia. It was reported that after the implant, the patient experienced unincorporated mesh, which was opened, and this appeared to be into the peritoneal cavity, infection/infected mesh, indurated tissue beneath it appeared to be a rind over the surface of the bowel, chronic granulation tissue, purulent material, adhesions, draining wound, mesh erosion, fistulous communication to the small bowel, bowel injury, murky fluid, attenuated tissue, foreign bodies in the anterior abdominal wall, large squamous cell cancer, recurrence, densely adhered mass, bowel showed less tendency to eviscerate from the abdominal cavity, abscess, open wound, mesh fragmented, area of fluctuance, chronic serositis, hemorrhage, necrosis, chronic draining tracts, fistula, and fluid collection. Post-operative patient treatment included revision surgery, excision of extensive dissection of the viscera, free this densely adherent mass from the anterior abdominal wall, adhesiolysis, excision of segment of bowel/fistula, wound vac, excision of mesh, excision of foreign bodies in the anterior abdominal wall, full-thickness excision of skin,/muscle/fascia, takedown of enterocutaneous fistula, small bowel resection with primary anastomosis, partial colectomy with end colostomy, partial omentectomy, excision of large squamous cell cancer, hernia repair with new mesh, abdominal irrigation/debridement, change of vacuum dressings, abdominal washout, incision/drainage of abscess, wound was copiously irrigated/debrided and packed with saline-soaked gauze, placement of drains, admission to hospital, and removal/irrigation of purulent material.
 
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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 80301
3035816943
MDR Report Key12029274
MDR Text Key258729983
Report Number9615742-2021-01540
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K982532
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/04/2005
Device Model NumberTET3030
Device Catalogue NumberTET3030
Device Lot Number99348TT3
Was Device Available for Evaluation? No
Date Manufacturer Received01/12/2022
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: 06/18/2021 Patient Sequence Number: 1
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