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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX¿ OPTIMIZED COMPOSITE MESH MESH, SURGICAL, POLYMERIC

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SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX¿ OPTIMIZED COMPOSITE MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number PCO2015
Device Problems Loss of or Failure to Bond (1068); Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993); Material Split, Cut or Torn (4008)
Patient Problems Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Anemia (1706); Cellulitis (1768); Dysphagia/ Odynophagia (1815); Edema (1820); Erythema (1840); Fever (1858); Foreign Body Reaction (1868); Pyrosis/Heartburn (1883); Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Pain (1994); Staphylococcus Aureus (2058); Seroma (2069); Swelling (2091); Burning Sensation (2146); Discharge (2225); Hernia (2240); Injury (2348); Ascites (2596); Abdominal Distention (2601); Weight Changes (2607); Fibrosis (3167); No Code Available (3191)
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 infection, recurrence, and adhesions. Post-operative patient treatment included multiple surgical revisions.
 
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.
 
Event Description
The patient¿s attorney alleged a deficiency against the device. The product was used for laparoscopic therapeutic treatment of a recurrent incisional hernia. It was reported that after implant, the patient experienced infection, recurrence, adhesions, gerd, weight gain, poor esophageal function, pain, mesh pulled away, bulge, heartburn, neck burning sensation, mesh pulled apart, anemia, abdominal pain, erythema, edema, cellulitis, phlegmon, serosanguinous fluid, seroma, encapsulated mesh, abscess, necrotic fat, swelling, fevers, enlarged liver, fluid behind the mesh with air bubbles in it, staphylococcus aureus, chronic inflammation, foreign body giant cell reaction, fluid collection, fibrosis, tortuous esophagus, and dysphagia. Post-operative patient treatment included multiple surgical revisions, redo nissen fundoplication, peg tube insertion 20-french, picc line placed for iv antibiotics, wound vac, hospitalized, oral antibiotics, pain medication, component separation bilaterally with lateral release, debridement, drainage of abscess, endoscopy with manometry catheter placement, and an esophagogastroscopy.
 
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 recurrent incisional hernia. It was reported that after implant, the patient experienced infection, recurrence, mesh pulled out on left side but not right, and adhesions. Post-operative patient treatment included multiple surgical revisions.
 
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Brand NameMESH SOFRADIM - PARIETEX¿ OPTIMIZED COMPOSITE MESH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
SOFRADIM PRODUCTION SAS
116 avenue du formans
trevoux 01600
FR 01600
MDR Report Key8188470
MDR Text Key131128955
Report Number9615742-2018-02884
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
K110815
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup,Followup
Report Date 02/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2013
Device Model NumberPCO2015
Device Catalogue NumberPCO2015
Device Lot NumberPIK00611
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/15/2019
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 12/21/2018 Patient Sequence Number: 1
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