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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 PCO12X
Device Problems Material Erosion (1214); Migration or Expulsion of Device (1395); Product Quality Problem (1506); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Erosion (1750); Eructate (1839); Unspecified Infection (1930); Pain (1994); Rash (2033); Injury (2348); Weight Changes (2607); No Code Available (3191); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 08/01/2012
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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 supraumbilical ventral hernia. It was reported that after implant, the patient experienced burping profusely, a bitter taste for three years, bowel issues, broke out in a rash, weight loss, infections, adhesions, abdominal pain, removed mesh was green, and ingrowth of mesh to muscle. Post-operative patient treatment included surgery to remove the mesh, rectus sheath excised, and staples and for lysis of adhesions.
 
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 supraumbilical ventral hernia. It was reported that after implant, the patient experienced burping profusely, a bitter taste for three years, bowel issues, broke out in a rash, weight loss, infections, adhesions, abdominal pain, and ingrowth of mesh to muscle. Post-operative patient treatment included surgery to remove the mesh and staples and for lysis of adhesions. After removing the mesh, it was green in color and her stomach was infected.
 
Event Description
According to the reporter: the customer had mesh implanted and has had some abnormal functionalities after. The patient has hat many infections. She had to have the mesh removed and it was spreading an infection. After removing the mesh it was green in color and her stomach was infected.
 
Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter: the customer had mesh implanted and has had some abnormal functionalities after. The patient was burping profusely, had a bitter taste for three years, had bowel issues, broke out in a rash, and weight loss. The patient has had many infections. She had to have the mesh removed approximately 3 years 4 months post op and it was spreading an infection. After removing the mesh it was green in color and her stomach was infected. The patient is currently feeling better but is still "burping. ".
 
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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
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 Key6646392
MDR Text Key109540789
Report Number9615742-2017-05161
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,Health Professional,User Facility
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 12/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/16/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2013
Device Model NumberPCO12X
Device Catalogue NumberPCO12X
Device Lot NumberPLJ00085
Was Device Available for Evaluation? No
Date Manufacturer Received11/10/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/18/2011
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: 06/16/2017 Patient Sequence Number: 1
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