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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 PCO12
Device Problems Defective Device (2588); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Erosion (1750); Emotional Changes (1831); Foreign Body Reaction (1868); Hematoma (1884); Hemorrhage/Bleeding (1888); Muscle Weakness (1967); Pain (1994); Seroma (2069); Swelling (2091); Urinary Retention (2119); Urinary Tract Infection (2120); Hernia (2240); Discomfort (2330); Injury (2348); Hematuria (2558); Blood Loss (2597); Abdominal Distention (2601); Dysuria (2684); Foreign Body In Patient (2687); No Code Available (3191); Constipation (3274); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); 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 a procedure where this device was implanted, the patient experienced chronic pain, adhesions, excision. After treatment, the patient experienced removal.
 
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 laparoscopic therapeutic treatment of an incisional hernia. It was reported that after implant, the patient experienced chronic pain, adhesions, mesh erosion into viscera, hematuria, uterine indentation, distention, seroma, rectus diastasis, thickening of anterior bladder wall, induration of the prevesicle fat, hematoma, urinary tract infection, blood loss, abdominal pain, swelling, constipation, difficulty urinating, foreign body in bladder, bulging, discomfort, thickening of appendix, recurrence, mental pain, injury, disability, impairment, loss of enjoyment of life, and defective mesh. Post-operative patient treatment included revision surgery, repair of hernia with mesh, antibiotics, daily straight catheterization, self-cath routinely for almost a year, and excision.
 
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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,fr
Manufacturer (Section G)
SOFRADIM PRODUCTION SAS
116 avenue du formans
trevoux,fr
Manufacturer Contact
tracy landers
5920 longbow drive
boulder,co, CT 80301
3035816943
MDR Report Key7674814
MDR Text Key113576852
Report Number9615742-2018-01531
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 Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 03/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/10/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPCO12
Device Catalogue NumberPCO12
Device Lot NumberPIH00244
Was Device Available for Evaluation? No
Date Manufacturer Received02/23/2022
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: 07/10/2018 Patient Sequence Number: 1
Treatment
UNKABSTACK(LOT#: UNKNOWN)
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