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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS SURGIPRO MESH, SURGICAL, POLYMERIC

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SOFRADIM PRODUCTION SAS SURGIPRO MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number SPM-35
Device Problems Degraded (1153); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Adhesion(s) (1695); Unspecified Infection (1930); Hernia (2240); Impaired Healing (2378); Obstruction/Occlusion (2422); Ascites (2596); Fluid Discharge (2686); Unspecified Tissue Injury (4559)
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: 8cm/3. 2" davol inc- mesh large circle with strap, product id: 5950009, lot # huar1431, exp. Date 05-28-2018. 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 the overlay implant, the patient experienced abdominal wound fluid collection, infection, thick mesh, incarcerated small bowel, adhesions, serous fluid, midline defect, bowel obstruction, and recurrence. Post-operative patient treatment included drainage of abdominal wound fluid collection, removal of mesh, wound vac, wound vac removed, lysis of adhesions, enterolysis to reduce small bowel, drainage of serous fluid, right and left anterior component separation, and hernia repair with new mesh.
 
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Brand NameSURGIPRO
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
tracy landers
5920 longbow drive
boulder, CO 80301
3035816943
MDR Report Key12025481
MDR Text Key257142901
Report Number9615742-2021-01475
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K915526
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 06/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2020
Device Model NumberSPM-35
Device Catalogue NumberSPM-35
Device Lot NumberA5B0864X
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/02/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/19/2015
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: 06/18/2021 Patient Sequence Number: 1
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