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U.S. Department of Health and Human Services

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

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SOFRADIM PRODUCTION SAS COVIDIEN PARIETEX MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number UNKNOWN PARIETEX PRODUCT
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Abscess (1690); Adhesion(s) (1695); Purulent Discharge (1812); Fever (1858); Foreign Body Reaction (1868); Granuloma (1876); Failure of Implant (1924); Unspecified Infection (1930); Inflammation (1932); Perforation (2001); Scarring (2061); Hernia (2240); Discomfort (2330); Injury (2348); Impaired Healing (2378); Obstruction/Occlusion (2422); Fibrosis (3167); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
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 an incisional hernia. It was reported that after the implant, the patient experienced granuloma, abscess, exposed mesh, infection, failure of mesh, adhesions, injury to the bladder, open wound, recurrence, obstruction, purulent material, hole in bladder, fever, discomfort, and scarring. Post-operative patient treatment included revision surgery, wound debridements, removal of mesh, small bowel resection with primary anastamosis, hernia repair with new mesh, hole in bladder repaired, antibiotics, and enterotomies repairs.
 
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Brand NameCOVIDIEN PARIETEX 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 Key10048225
MDR Text Key190665271
Report Number9615742-2020-01029
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 Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 07/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/12/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNKNOWN PARIETEX PRODUCT
Device Catalogue NumberUNKNOWN PARIETEX PRODUCT
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/01/2020
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: 05/12/2020 Patient Sequence Number: 1
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