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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 PCO12X
Device Problems Degraded (1153); Migration or Expulsion of Device (1395); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Adhesion(s) (1695); Inflammation (1932); Ischemia (1942); Nausea (1970); Pain (1994); Hernia (2240); Discomfort (2330); Obstruction/Occlusion (2422); 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 a incisional hernia. It was reported that after the implant, the patient experienced adhesions, benign fibrofatty tissue, inflammation, bowel obstruction, ischemic bowel, pain, tenderness, nausea, mesh thickened, mesh contracted, mesh folded, nonincorporated mesh, and hernia recurrence. Post-operative patient treatment included mesh removal surgery, partial omentectomy, lysis of adhesions, repair of hernia with mesh, open component separation technique, bilateral component separation with creation trunk myofascial flaps, laparotomy enterolysis, and exploratory laparotomy.
 
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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 Key11986208
MDR Text Key255772852
Report Number9615742-2021-01451
Device Sequence Number1
Product Code FTL
UDI-Device Identifier10884521179745
UDI-Public10884521179745
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
Report Date 06/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2013
Device Model NumberPCO12X
Device Catalogue NumberPCO12X
Device Lot NumberPLF00519
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/26/2021
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: 06/11/2021 Patient Sequence Number: 1
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