Catalog Number 5400010008ITL |
Device Problem
Packaging Problem (3007)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 05/10/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
A follow up report will be filed once the quality investigation is complete.Awaiting device return.
|
|
Event Description
|
It was reported that there was a potential sterility breach on the packaging of the device, it was noted that there was a hair in the pack prior to a surgical procedure.It was also reported that this event did not occur during a surgical procedure.It was further reported there was a minimal delay to get a replacement product.
|
|
Event Description
|
It was reported that there was a potential sterility breach on the packaging of the device, it was noted that there was a hair in the pack prior to a surgical procedure.It was also reported that this event did not occur during a surgical procedure.It was further reported there was a minimal delay to get a replacement product.
|
|
Manufacturer Narrative
|
H6: the quality investigation is complete.
|
|
Search Alerts/Recalls
|