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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 PCO3020
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Bacterial Infection (1735); Erythema (1840); Fever (1858); Fistula (1862); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Scar Tissue (2060); Hernia (2240); Ascites (2596); Fibrosis (3167); Respiratory Insufficiency (4462); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative

Concomitant medical products: abstack20 5mm sgl use abs dev 20 tacks, lot number: u8d17. Abstack20 5mm sgl use abs dev 20 tacks, lot number: u8e79. 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 laparoscopic therapeutic treatment of a ventral hernia. It was reported that after the implant, the patient experienced abscess cavity with enteric contents, fistula, hernia recurrence, adhesions, fluid collection, gam + cocci, gram ¿ bacilli, polymorphonuclear cells, eikenella corrodens, many mixed anaerobic flora, very rare streptococcus alpha hemolytic, very rare candida albicans, fibrous tissue, inflammation, fibromembranous tissue, sclerosis, granulation, fever, abdominal pain, erythema, respiratory distress, scar tissue, mild oozing (blood), and infection. Po st-operative patient treatment included incision and drainage of fluid collections and lower abdominal wall abscess, mesh removal, dissection of 3 loops of bowel adhered to prior mesh, 3rd loop that was a prior anastomis site fistulized into prior mesh, lysis of adhesions from prior mesh/abdominal wall/omentum, hernia repair/abdominal wall reconstruction with mesh, bowel resection, admission to hospital, medication, antibiotics, hemostatic agents, and revision surgery.

 
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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 80301
3035816943
MDR Report Key12318406
MDR Text Key266395739
Report Number9615742-2021-01917
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 08/13/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/13/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/31/2009
Device MODEL NumberPCO3020
Device Catalogue NumberPCO3020
Device LOT NumberPGC00748
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/28/2021
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: 08/13/2021 Patient Sequence Number: 1
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