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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 PCO2015
Device Problems Degraded (1153); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Purulent Discharge (1812); Unspecified Infection (1930); Hernia (2240); Impaired Healing (2378); Obstruction/Occlusion (2422); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative

Concomitant product: sorbafix absorbable fixation system (product id: 0113080, lot number: dati0013) (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 incisional hernia. It was reported that after implant, the patient experienced small bowel obstruction, infection, feculent/foul smelling drainage from wound, exposed mesh, non-healing open wound, calcified mesh, recurrence, abdominal pain, firm nodules, fever, mild tachycardia, necrosis, weight loss, loss of appetite, discomfort, subcutaneous mass, attenuation, and adhesions. Post-operative patient treatment included partial removal of mesh, full removal of mesh, wound vac, wound debridement, adhesiolysis, stamm gastrostomy tube placement in remnant stomach, peritoneal biopsy x3, mesenteric nodule biopsy x1, antibiotics, debridement of skin/subcutaneous tissue/muscle/fascia for necrotizing soft tissue infection, abdominal washout, abthera placement, placement of wittman patch, prolonged hospitalization, removal of wittman patch, removal of jp drain, abdominal washout, creation of bilateral myofascial flaps, closure of abdominal wall fascia, subcutaneous tissues packed, bilateral posterior component separation (transversus abdominis muscle flaps), removal of deep foreign bodies, muscle x 4, removal deep foreign bodies, peritoneum x 7, regional block (transversus abdominis plane block), bilateral with liposomal bupivacaine, adjacent tissue transfer, incisional vac, scar excision, subcutaneous mass resection, removal of tacks/sutures, and hernia repair with new mesh.

 
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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
lisa hernandez
60 middletown ave
north haven, CT 06473
2034925563
MDR Report Key11570723
MDR Text Key242383299
Report Number9615742-2021-00646
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK040998
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 03/25/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/25/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/31/2013
Device MODEL NumberPCO2015
Device Catalogue NumberPCO2015
Device LOT NumberPIK00243
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/10/2021
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: 03/25/2021 Patient Sequence Number: 1
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