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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 PCO1510
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Adhesion(s) (1695); Cellulitis (1768); Purulent Discharge (1812); Erythema (1840); Inflammation (1932); Muscle Weakness (1967); Pain (1994); Perforation (2001); Hernia (2240); Injury (2348); Obstruction/Occlusion (2422); No Code Available (3191); Unspecified Tissue Injury (4559)
Event Type  Injury  
Manufacturer Narrative
(b)(4). 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 bowel perforation, adhesions, dilated small bowel, inflammation, purulent material, attenuated fascia, erythema, recurrence, and cellulitis. Post-operative patient treatment included revision surgery, resection of perforated small intestine, ileostomy/hartmann procedure, primary closure of fascia, wound left open/packed with gauze, post-operatively in serious condition, prolonged hospitalization, and bowel 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
tracy landers
5920 longbow drive
boulder,co, CT 80301
3035816943
MDR Report Key10513854
MDR Text Key206301416
Report Number9615742-2020-01985
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 Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 01/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2014
Device Model NumberPCO1510
Device Catalogue NumberPCO1510
Device Lot NumberPJD00669
Was Device Available for Evaluation? No
Date Manufacturer Received12/22/2021
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: 09/10/2020 Patient Sequence Number: 1
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