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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 TCM3030
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); Purulent Discharge (1812); Unspecified Infection (1930); Nausea (1970); Pain (1994); Vomiting (2144); 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
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 recurrence, adhesions, obstruction, enterotomy, purulent material, open wound, mesh erosion, infection, and abscess. Post-operative patient treatment included hernia repair with new mesh, mesh revision, removal of mesh, drain placement, small bowel resection with primary anastomosis, lysis of adhesions, removal of drain, wound vac, purulent material expressed, and incision/drainage of abscess.
 
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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
tracy landers
5920 longbow drive
boulder, CO 80301
3035816943
MDR Report Key12254047
MDR Text Key264336453
Report Number9615742-2021-01860
Device Sequence Number1
Product Code FTL
UDI-Device Identifier10884521178922
UDI-Public10884521178922
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K090858
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 08/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2017
Device Model NumberTCM3030
Device Catalogue NumberTCM3030
Device Lot NumberSMG00138
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/14/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/19/2012
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: 07/30/2021 Patient Sequence Number: 1
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