|
Catalog Number VMC4005 |
Device Problem
Device Packaging Compromised (2916)
|
Patient Problem
No Patient Involvement (2645)
|
Event Type
malfunction
|
Manufacturer Narrative
|
Ate of occurrence: 2017.The device was not returned, therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
|
|
Event Description
|
It was reported that packaging of a tur irrigation set was already opened before use.There was no patient involvement.No additional information is available.
|
|
Manufacturer Narrative
|
A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
|
|
Search Alerts/Recalls
|
|
|