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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 PCO3020X
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Asthma (1726); Emotional Changes (1831); High Blood Pressure/ Hypertension (1908); Nausea (1970); Pain (1994); Hernia (2240); Anxiety (2328); Injury (2348); Depression (2361); Blood Loss (2597); 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 treatment of a ventral hernia. It was reported that after implant, the patient experienced adhesions, abdominal pain, abdominal surgery complicated by bleeding with emergent exploration for hemorrhage, nausea, constipation, pain, rectal bleeding, hematochezia, vaginismus, dyspareunia, hypertension, asthma, depressive disorder, anxiety and recurrence. Post-operative patient treatment included surgical revision ((b)(6) 2016). Relevant tests/lab data: on (b)(6) 2016: wound culture from lower abdominal wall with no growth. Labs abnormal for sodium 133, chloride 96, glucose 113. Preop ct scan (date unknown) showed evidence of small intestine of the bladder [sic] herniating through the inferior portion of her midline incision, inferior to her previous mesh.

 
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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 Key8318137
MDR Text Key135451098
Report Number9615742-2019-00235
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK110815
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/16/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/07/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/31/2018
Device MODEL NumberPCO3020X
Device Catalogue NumberPCO3020X
Device LOT NumberPNK0104X
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/19/2019
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured11/16/2013
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: 02/07/2019 Patient Sequence Number: 1
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