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U.S. Department of Health and Human Services

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

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SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX COMPOSITE MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number PCO2520
Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Erosion (1750); Purulent Discharge (1812); Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Scar Tissue (2060); Hernia (2240); Impaired Healing (2378); Fluid Discharge (2686); 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 ventral hernia. It was reported that after the implant, the patient experienced adhesions, recurrent drainage from midline wound, small bowel abscess, serosal tears, infection, desmoplastic reaction, purulent material, large inflammatory mass, migrated mesh, non-healing wound, scarring, abdominal pain, recurrence, enterotomy, mesh erosion, and necrosis. Post-operative patient treatment included revision surgery, hernia repair with sutures, resection of abdominal wall with excision of umbilicus, revision of mesh, removal of mesh, dissection of adhesions, repair of serosal tears, debridement of necrotic tissue/non-viable skin, hernia repair with new mesh, repair of small bowel enterotomy, lysis of adhesions, sigmoid resection with primary anastomosis, excision of mesh, component separation, wound closure of myocutaneous advancement flaps, and drainage of purulent material.

 
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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 Key11861144
MDR Text Key251924390
Report Number9615742-2021-01344
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK040998
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 05/20/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/20/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/31/2012
Device MODEL NumberPCO2520
Device Catalogue NumberPCO2520
Device LOT NumberPIA00248
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/05/2021
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: 05/20/2021 Patient Sequence Number: 1
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