|
Catalog Number 5955600 |
Device Problem
Material Separation (1562)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/17/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
The subject device was returned and has been evaluated.No manufacturing anomalies were found.Evaluation finds the st coating is separated from areas on the mesh as reported, resulting in a void of the hydrogel barrier.Evaluation identified that the mesh had been hydrated by the user, how long the mesh had been hydrated for is unknown.The instructions-for-use states the mesh should be hydrated for no more than 1-3 seconds prior to use and rolled immediately to protect the bioresorbable coating.The gel is noted to be balling up and pulling away from the mesh; it is known that damage to the hydrogel may occur if the mesh is hydrated longer than the recommended 1-3 seconds.Based on the sample evaluation and the investigation performed, the separation of the hydrogel inadvertently occurred during subsequent handling and preparation for use.A review of the manufacturing records was performed for the subject lot and found that the lot was manufactured to the specification.To date, this is the only reported complaint for this manufacturing lot of 120 units released for distribution in september, 2020.
|
|
Event Description
|
As reported, during an unspecified procedure on (b)(6) 2021, a bard/davol ventralight st w/echo 6¿ mesh was hydrated (duration unknown), and placed in the patient.It was noted that the mesh was ¿separating from itself¿ and the surgeon removed this piece of mesh and placed a new piece.There was no reported patient injury.
|
|
Search Alerts/Recalls
|
|
|