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U.S. Department of Health and Human Services

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

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SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX OPTIMIZED COMPOSITE MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number PCO6VP
Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Purulent Discharge (1812); Edema (1820); Foreign Body Reaction (1868); Failure of Implant (1924); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Swelling (2091); Discomfort (2330); Injury (2348); 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 a hernia. It was reported that after implant, the patient experienced inflammation, rejection of mesh and pain. Post-operative patient treatment included a revision surgery.
 
Manufacturer Narrative
(b)(4). If information is provided in the future, a supplemental report will be issued.
 
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Brand NameMESH SOFRADIM - PARIETEX OPTIMIZED COMPOSITE MESH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
SOFRADIM PRODUCTION SAS
116 avenue du formans
trevoux 01600
FR 01600
MDR Report Key8538288
MDR Text Key142724609
Report Number9615742-2019-01460
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
K120506
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 07/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/22/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2019
Device Model NumberPCO6VP
Device Catalogue NumberPCO6VP
Device Lot NumberPOC8040
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/01/2020
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 04/22/2019 Patient Sequence Number: 1
Treatment
UNKNOWN MESH POSITIONING STRAPS
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