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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 PCO2015
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 Wound Dehiscence (1154); Abdominal Pain (1685); Adhesion(s) (1695); Erosion (1750); Erythema (1840); Fever (1858); Unspecified Infection (1930); Nausea (1970); Pain (1994); Staphylococcus Aureus (2058); Vomiting (2144); Dizziness (2194); Discharge (2225); Myalgia (2238); Hernia (2240); Discomfort (2330); Injury (2348); Impaired Healing (2378); Obstruction/Occlusion (2422); Abdominal Distention (2601); Bowel Perforation (2668); No Code Available (3191); Constipation (3274)
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 laparoscopic treatment of a ventral incisional hernia. It was reported that after implant, the patient experienced small bowel obstruction, pain, bowel perforation, mesh erosion into omentum, small bowel resection, bowel adhesions, abdominal pain, nausea, vomiting, wound dehiscence, recurrent incisional hernia, progressive large bulge in llq, constipation, infected chronic non-healing abdominal wound, mild erythema, myalgias, dizziness, abdominal discomfort, and fevers. Post-operative treatment included removal surgery. The product had been used with an unknown protack device.
 
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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
lisa hernandez
60 middletown ave
north haven, CT 06473
2034925563
MDR Report Key9149313
MDR Text Key161047942
Report Number9615742-2019-03359
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 consumer
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 06/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/02/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/30/2016
Device Model NumberPCO2015
Device Catalogue NumberPCO2015
Device Lot NumberPLI00006
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/20/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/12/2011
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: 10/02/2019 Patient Sequence Number: 1
Treatment
UNKNOWN PROTACK DEVICE (LOT# UNKNOWN)
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