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U.S. Department of Health and Human Services

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

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SOFRADIM PRODUCTION SAS PARIETEX MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number PCO3728X
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Erosion (1750); Calcium Deposits/Calcification (1758); Edema (1820); Fever (1858); Fistula (1862); Foreign Body Reaction (1868); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Inflammation (1932); Ischemia (1942); Nausea (1970); Necrosis (1971); Pain (1994); Scarring (2061); Swelling (2091); Tachycardia (2095); Hernia (2240); Discomfort (2330); Injury (2348); Impaired Healing (2378); Obstruction/Occlusion (2422); Abdominal Distention (2601); Fibrosis (3167); No Code Available (3191); Constipation (3274)
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 laparoscopic treatment of a ventral incisional hernia. It was reported that after implant, the patient experienced pain, bowel obstruction, adhesions,and recurrence. Post-operative patient treatment included revision surgery.
 
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Brand NamePARIETEX
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
15 hampshire street
mansfield,ma, CT 02048
2034925563
MDR Report Key9668097
MDR Text Key177745607
Report Number9615742-2020-00330
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110815
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,Followup
Report Date 03/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/04/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2014
Device Model NumberPCO3728X
Device Catalogue NumberPCO3728X
Device Lot NumberPME00448
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/26/2020
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: 02/04/2020 Patient Sequence Number: 1
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