Model Number SYM3728 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Torn Material (3024)
|
Patient Problem
No Code Available (3191)
|
Event Date 08/10/2017 |
Event Type
Injury
|
Manufacturer Narrative
|
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
According the reporter: the patient underwent a laparoscopic recurrent incisional ventral hernia repair.Four days post op, the patient underwent an exploratory laparotomy to remove the graft which lead to extended hospitalization and caused temporary injury to the patient.The surgeon described the mesh as "faulty." the current patient status is inpatient icu.An additional operation will be performed to correct the issue.
|
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
According the reporter: as per the additional information received, the surgeon described the sutures tore from the mesh, it was defective and the product dislodged.Actual mesh ripped on the left edge with 3 or 4 holes.Mesh was hydrated before putting it in.Patient was taken back old mesh removed and new mesh put in.Sutured fixation system was used.Patient is doing fine now.Patient medical history: obese patient with large ventral hernia and loss of domain.
|
|
Manufacturer Narrative
|
Evaluation summary: the visual examination of the returned sample shows that: the sample was not returned in its original packaging.It was placed in a biohazard bag and the mesh was found contaminated by blood.The mesh was found cut, mesh dimension around 25x24 instead of 37x28 initially.The textile knitting was found as expected however the collagen seems to be partially reduced.Four holes of different sizes are visible: - hole n°1: defect length 3 cm, defect width 2 stitches - hole n°2: defect length 2 cm, defect width 3 stitches - hole n°3: defect length 12 cm, defect width 5 cm - hole n°4: defect length 1 cm, defect width 3 stitches conclusion of the visual examination determined that excessive tension is highly suspected.If information is provided in the future, a supplemental report will be issued.
|
|
Search Alerts/Recalls
|