Catalog Number 328519 |
Device Problem
Missing Information (4053)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/01/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
E.1.(b)(6).H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
|
|
Event Description
|
It was reported that the had missing label information.The following was recieved by the initial reporter: consumer reported lot # 7178872 from bag does not have an exp date on the bag.
|
|
Manufacturer Narrative
|
H.6.Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.This is the 1st complaint for the reported lot number.A review of the manufacturing records was performed, and no non-conformances were raised in association with this type of event for this lot.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.Based on the above, no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) is required at this time.
|
|
Event Description
|
It was reported that the had missing label information.The following was recieved by the initial reporter: consumer reported lot # 7178872 from bag does not have an exp date on the bag.
|
|
Search Alerts/Recalls
|