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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 PCO9
Device Problems Degraded (1153); Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Corneal Pannus (1447); Abdominal Pain (1685); Adhesion(s) (1695); Anemia (1706); Asthma (1726); Bacterial Infection (1735); Cellulitis (1768); Granuloma (1876); Unspecified Infection (1930); Necrosis (1971); Pain (1994); Scar Tissue (2060); Seroma (2069); Urinary Tract Infection (2120); Burning Sensation (2146); Hernia (2240); Impaired Healing (2378); Obstruction/Occlusion (2422); Ascites (2596); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative

Concomitant product: pco20 parietex comp 3d py 20 cir nothr (lot# pkf00370), abstack20 5 mm sgl use abs dev 20 tacks (lot# unknown), 174006 protack 5 mm disp in (lot# p8k0144). (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 laparoscopic therapeutic treatment of a ventral hernia. It was reported that after implant, the patient experienced infection, seroma, abdominal wall fluid, abdominal wall cellulitis, omentum adhesions to mesh, hernia recurrence, obstruction, suture granuloma, chronic pain, open wound, (b)(6), pseudomonas aeruginosa, fluid collection, abdominal pain, asthma exacerbation, felt abdomen "ripping open", diastasis recti, pannus, burning/stretching sensation, scarring, attenuation, granuloma, anemia, uti, necrotic skin, mesh traveling laterally, and granulating mesh. Post-operative patient treatment included seroma fluid drainage, adhesion removal, mesh removal, hernia repair surgery with implant of new mesh, abdominal debridement, aspiration of fluid collection, admission to hospital, complex abdominal wall reconstruction, component separation of the abdominal wall with bilateral ramirez external oblique anterior releases and myofascial advancement, negative pressure wound dressing, removal of tacks/sutures, primary closure of fascia, medication, debridement of necrotic skin/subcutaneous tissue, and wound vac.

 
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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 Key11822095
MDR Text Key250875611
Report Number9615742-2021-01107
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 05/13/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/13/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/31/2015
Device MODEL NumberPCO9
Device Catalogue NumberPCO9
Device LOT NumberPKH00365
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/28/2021
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: 05/13/2021 Patient Sequence Number: 1
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