|
Catalog Number 5955460 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 11/03/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
As reported, there was a gelatin like substance on the polypropylene side of the ventralight st mesh with echo ps after insertion.There was no reported patient harm/injury as a result of the reported issue.The subject device remains implanted and is not available for evaluation.Based on the available information, we are unable to determine a definitive root cause for the reported event.While no determination can be made, based on the described greenish jelly material, it is possible this material was some residual st material that following hydration may have been observed on the implant.A review of the manufacturing records was performed for the subject lot and found that the lot was manufactured to specification.To date, this is the only reported complaint from this manufacturing lot of (b)(4) units released for distribution in june, 2019.Should additional information be provided, a supplemental mdr will be submitted.
|
|
Event Description
|
As reported, on (b)(6) 2020, the patient was implanted with ventralight st mesh with echo ps 4"x6" ellipse during a laparoscopic spigelian hernia repair.The visual inspection of the mesh prior to insertion showed with no evidence of abnormality.Prior to insertion, the ventralight st mesh was hydrated as directed, about 1-3 seconds and was positioned using the echo balloon without any issue.As reported, once the mesh was inserted and the surgeon started to fixate the mesh, a greenish color gelatin (jelly) like substance was noted on the polypropylene side of the mesh.A surgical sponge was used to absorb some of the material in the cavity and scant amounts of the viscous material were present.Irrigation of the cavity was done at the end of the case and the discoloration was no longer observed.As reported, the surgeon did not feel there was any void to the sepra coating on the mesh.There was no reported patient harm/injury as a result of the reported issue.
|
|
Search Alerts/Recalls
|
|
|