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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 PCO3020FX
Device Problems Degraded (1153); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Tissue Damage (2104); No Code Available (3191)
Event Date 02/12/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, during use, patient reported symptoms evident of possible adhesions. Open laparotomy was done as an intervention to remove implanted mesh adhesions and bowel resection. Transracial sutures were evident at time of mesh removal and it was partially integrated with bowel adhesions that is evident. There was an unanticipated tissue loss and damage as a result of this problem and was treated by performing bowel resection. It requires more than 6 hours to remove adhesions and the implanted mesh. Incision was extended more than 1 inch due to the problem. Patient remains in the hospital.
 
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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
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 Key8399377
MDR Text Key138105050
Report Number9615742-2019-00414
Device Sequence Number1
Product Code FTL
UDI-Device Identifier10884521179844
UDI-Public10884521179844
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K110663
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/07/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2020
Device Model NumberPCO3020FX
Device Catalogue NumberPCO3020FX
Device Lot NumberPPF0412X
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/13/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/24/2015
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: 03/07/2019 Patient Sequence Number: 1
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