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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 PCO2520
Device Problems Material Perforation (2205); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Ossification (1428); Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Purulent Discharge (1812); Fever (1858); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Scarring (2061); Vomiting (2144); Hernia (2240); Injury (2348); Impaired Healing (2378); Respiratory Failure (2484); Ascites (2596); Bowel Perforation (2668); 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 perforated ileocolonic bowel anastomosis with abscess formation, sudden onset of retching, abdominal pain, bowel thickening/inflammation, puss under areas of mesh, infection, non-healing wound, fever, ventral hernia, incisional hernia, heterotopic ossification, dilated bowel, and abscess formation in the hepatorenal space on the right side. Post-operative treatment included repair of hole in small bowel, vac dressing, intubation within icu for 2 weeks, bilateral pleural effusions with atelectasis, repair of abdominal ventral hernia with mesh, debridement/washout of abdominal wound with removal of infected pieces of mesh, recurrent incisional hernia repair, and mesh resection.
 
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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 Key8497112
MDR Text Key141381418
Report Number9615742-2019-01137
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110815
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
Report Date 10/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/09/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPCO2520
Device Catalogue NumberPCO2520
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/15/2019
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: 04/09/2019 Patient Sequence Number: 1
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