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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 PCO1510
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Torn Material (3024); Material Split, Cut or Torn (4008)
Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Pain (1994); Scarring (2061); Seroma (2069); Hernia (2240); Injury (2348); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information, medical history: diabetes mellitus type 2, resistant to insulin, obesity, hyperlipidemia, spinal stenosis, ventral hernia, neuropathy, scoliosis with harrington rob, uterine malignancy surgical history: spinal surgery x2, d/t ski accident, bony fusion, tah bso (b)(6) 2011 allergies: penicillin, codeine, lisinopril, prednisone, bananas, latex, iv contrast.
 
Manufacturer Narrative
(b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Per additional information received the patient had a mesh device surgically implanted into the abdomen for repair of an umbilical hernia. The indications for implantation of the abdominal mesh was incarcerated (omentum) ventral (umbilical)hernia. The post operative complications developed following abdominal placement of surgical mesh was a seroma. Following mesh revision the patient required additional surgeries. Underwent a total abdominal hysterectomy and bilateral salpingoophorectomy on (b)(6) 2011 for endometrial cancer; it is unknown how this was performed and if the mesh was cut during this procedure. Recurrent incarcerated hernia was repaired on (b)(6) 2013 where the findings included multiple loops of bowel and omentum adherent to the mesh in the midline, appeared to be a hole in the previously placed mesh to the left of midline. The hole was approximately 2 inches in diameter and was filled with approximately 150ml of omental fat. Defect was patched over with ventralight.
 
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 umbilical hernia. It was reported that after the implant, the patient experienced seroma, recurrence, hole in mesh, abdominal pain, scarring, and adhesions. Post-operative patient treatment included abdominal hysterectomy, bilateral salpingo oophorectomy, lysis of adhesions, and hernia repair with new mesh.
 
Event Description
The patient's attorney alleged a deficiency against the device resulting in an unspecified adverse outcome. Product was used for therapeutic treatment. The patient had a mesh device surgically implanted into the abdomen for repair of an umbilical hernia. Approximately 8 years and 5 months post op the patient required further surgery to repair an abdominal hernia. After that surgery the patient discovered that the mesh was found to have split open, thereby having been the cause of immense ongoing and prolonged pain and suffering until the mesh was removed surgically and replaced by a different product.
 
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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
lisa hernandez
60 middletown ave
north haven, CT 06473
2034925563
MDR Report Key6737249
MDR Text Key109408378
Report Number9615742-2017-05189
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
Type of Report Initial,Followup,Followup,Followup
Report Date 08/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/24/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2010
Device Model NumberPCO1510
Device Catalogue NumberPCO1510
Device Lot NumberPFB00514
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/22/2020
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: 07/24/2017 Patient Sequence Number: 1
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