|
Catalog Number 20-1037 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
|
Patient Problem
No Information (3190)
|
Event Date 11/05/2015 |
Event Type
malfunction
|
Manufacturer Narrative
|
Upon completion of the investigation a follow up report will be filed.
|
|
Event Description
|
A hair was found in the sterile package.Event occurred prior to surgery, no delays, no adverse consequences; surgeon didn't open package, sent it to purchasing.On (b)(6) 2015 per rep, reported contamination inside sterile barrier.
|
|
Manufacturer Narrative
|
It was initially reported that the device would be returned for evaluation.Multiple attempts to obtain the sample were unsuccessful.This report has been updated to reflect the corrected information.Complaint sample was not returned to codman; therefore, an evaluation of the device could not be performed.A review of manufacturing records was performed by the supplier and no nonconformances were noted.The cause(s) of the difficulty reported by the customer could not be determined.If the complaint sample becomes available, this complaint will be reopened, and the respective evaluation performed.At present, we consider this complaint to be closed.Trends will be monitored for this or similar complaints.Device not returned.
|
|
Search Alerts/Recalls
|
|
|