Catalog Number 121932152 |
Device Problem
Device Disinfection Or Sterilization Issue (2909)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 12/19/2017 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Event Description
|
Customer wrote: "i did a microbiological check-up on an implant on (b)(60 2017 at 07:30.The examination was carried out by first opening the box, then hand disinfecting of the staff´s hand and then taking the sample.The result shocks me, as the sampling aerobic spore formers shows turf growth 16 - 50 cfu.As you can read in the literature, a disinfection of the outer packaging is without effect." customer is asking for a statement.Customer does not remember ref/lot; a list of possible samples is attached.
|
|
Manufacturer Narrative
|
Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Search Alerts/Recalls
|