• 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 PERMACOL MESH, SURGICAL

  • 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 PERMACOL MESH, SURGICAL Back to Search Results
Model Number P152030
Device Problems Material Erosion (1214); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Adhesion(s) (1695); Erosion (1750); Purulent Discharge (1812); Emotional Changes (1831); Fever (1858); Fistula (1862); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Discharge (2225); Excessive Tear Production (2235); Hernia (2240); Injury (2348); Impaired Healing (2378); Fluid Discharge (2686); 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 a ventral hernia. It was reported that after implant, the patient experienced fistula, enterocutaneous fistula draining feculent material through skin, dense adhesions, mesh that had eroded into the bowel, infection, dense inflammatory tissue, and serosal tear. Post-operative treatment included small bowel resection, wound vac and multiple revision surgeries.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePERMACOL
Type of DeviceMESH, SURGICAL
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, CT 80301
3035816943
MDR Report Key8714819
MDR Text Key148526759
Report Number9617613-2019-00104
Device Sequence Number1
Product Code FTM
UDI-Device Identifier10884523000207
UDI-Public10884523000207
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K120605
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,Followup
Report Date 10/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/12/2010
Device Model NumberP152030
Device Catalogue NumberP152030
Device Lot Number07B11-2
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/22/2021
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: 06/19/2019 Patient Sequence Number: 1
-
-