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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 PCO1510OS
Device Problems Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Adhesion(s) (1695); Purulent Discharge (1812); Emotional Changes (1831); Unspecified Infection (1930); Pain (1994); Hernia (2240); Impaired Healing (2378); Ascites (2596); Fluid Discharge (2686); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative
(b)(4). 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 ventral hernia. It was reported that after the implant, the patient experienced recurrence, abdominal wall fluid, draining sinus, infection, abscess, adhesions, sinus tract, purulent material, open wound, and leukocytes. Post-operative patient treatment included revision surgery, excisional debridement of draining sinus of abdominal wall, guided abscess drainage, sinus tract evacuated, wound irrigated/packed, diagnostic laparoscopy, lysis of adhesions, bilateral posterior component separation with bilateral transversus abdominis release, debridement of abdominal wall including skin/subcutaneous tissue/fascia/rectus muscle, removal of mesh, intra-abdominal omental flap, scar revision, wound vac, removal of tacks, purulent material excised, ileostomy revision, and hernia repair with new mesh.
 
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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, CT 80301
3035816943
MDR Report Key11602916
MDR Text Key243380627
Report Number9615742-2021-00732
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K050187
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2011
Device Model NumberPCO1510OS
Device Catalogue NumberPCO1510OS
Device Lot NumberPHA00364
Was Device Available for Evaluation? No
Date Manufacturer Received03/30/2022
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: 04/01/2021 Patient Sequence Number: 1
Treatment
UNKNOWN PROTACK (LOT# UNKNOWN)
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