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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 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); Fever (1858); Hematoma (1884); Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Nausea (1970); Pain (1994); Renal Failure (2041); Seroma (2069); Hernia (2240); Distress (2329); Injury (2348); Impaired Healing (2378); Obstruction/Occlusion (2422); Ascites (2596); Abdominal Distention (2601); No Code Available (3191); Thrombosis/Thrombus (4440); 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 hernia. It was reported that after implant, the patient experienced chronic pain, recurrence of hernia, and dense adhesions. Treatment required included surgical revision of the mesh.
 
Event Description
The patient¿s attorney alleged a deficiency against the device. The product was used for therapeutic treatment of an incisional hernia. It was reported that after implant, the patient experienced chronic pain, recurrence of hernia, infection of a cavity beneath the mesh filled with clot/pus, abscess, open wound, hematoma, fluid collections, gi distress, pain, nausea, fevers, hypotensions, decreased hematocrit, altered mental status, seroma, distention, renal failure, postop ileus, leukocytosis, mental pain, disability, impairment, loss of enjoyment of life, defective mesh, and dense adhesions. Post-operative patient treatment included surgical revision, adhesiolysis, explant of the mesh, implant of new mesh, transfusion of 4 units packed red blood cells, iv antibiotics, oxygen, diuresis, ng tube for drainage, pain medications, iv fluids, advair, aspiration of seroma, drain placed, and wound/hematoma evacuation.
 
Manufacturer Narrative
(b)(4). 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 an incisional hernia. It was reported that after implant, the patient experienced chronic pain, recurrence of hernia, infection of a cavity beneath the mesh filled with clot/pus, abscess, open wound with hematoma, and dense adhesions. Treatment required included surgical revision, adhesiolysis, explant of the mesh, implant of new mesh, and wound/hematoma evacuation.
 
Event Description
The patient¿s attorney alleged a deficiency against the device. The product was used for therapeutic treatment of an incisional hernia. It was reported that after implant, the patient experienced chronic pain, recurrence of hernia, infection of a cavity beneath the mesh filled with clot/pus, abscess, open wound, hematoma, fluid collections, gi distress, pain, nausea, fevers, hypotensions, decreased hematocrit, altered mental status, seroma, distention, renal failure, postop ileus, and dense adhesions. Post-operative patient treatment included surgical revision, adhesiolysis, explant of the mesh, implant of new mesh, transfusion of 4 units packed red blood cells, iv antibiotics, oxygen, diuresis, ng tube for drainage, pain medications, iv fluids, advair, aspiration of seroma, drain placed, and wound/hematoma evacuation.
 
Manufacturer Narrative
This information was received as a part of an extensive mesh litigation submission to medtronic. The fda was notified of this large complaint receipt. Due to the volume of complaint information received by medtronic, this resulted in a report beyond the 30 day target. (b)(4). If information is provided in the future, a supplemental report will be issued.
 
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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 Key7997615
MDR Text Key124788309
Report Number9615742-2018-02399
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K040998
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 02/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/23/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2004
Device Model NumberPCO2520
Device Catalogue NumberPCO2520
Device Lot NumberD22343PCO25
Was Device Available for Evaluation? No
Date Manufacturer Received01/26/2022
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: 10/23/2018 Patient Sequence Number: 1
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