• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX COMPOSITE MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number PCO1510OS
Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Adhesion(s) (1695); Purulent Discharge (1812); Fistula (1862); Unspecified Infection (1930); Pain (1994); Scar Tissue (2060); Hernia (2240); Impaired Healing (2378); Obstruction/Occlusion (2422); Abdominal Distention (2601); Fibrosis (3167); Unspecified Tissue Injury (4559)
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 and umbilical hernia. It was reported that after implant, the patient experienced pain, bowel obstruction, infection, fistula, mesh migration, adhesions, distended bowel, scar tissue, recurrence, fibrinous tissue, purulent tissue, loose mesh edges, and chronic abdominal wound. Post-operative patient treatment included revision surgery, lysis of adhesions, excisional debridement of skin/ subcutaneous tissue/ fascia/ mesh, loose edges of mesh excised, and release small bowel obstruction.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMESH SOFRADIM - PARIETEX COMPOSITE 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
tracy landers
5920 longbow drive
boulder, CO 80301
3035816943
MDR Report Key12652669
MDR Text Key277099362
Report Number9615742-2021-02322
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
Report Date 10/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/28/2011
Device Model NumberPCO1510OS
Device Catalogue NumberPCO1510OS
Device Lot NumberPHA00161
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/29/2021
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: 10/18/2021 Patient Sequence Number: 1
-
-