Brand Name | CUB PEDIATRIC CRIB- HYD BASE |
Type of Device | BED, PEDIATRIC OPEN HOSPITAL |
Manufacturer (Section D) |
STRYKER MEDICAL-KALAMAZOO |
3800 east centre avenue |
portage MI 49002 |
|
Manufacturer (Section G) |
STRYKER MEDICAL-KALAMAZOO |
3800 east centre avenue |
|
portage MI 49002 |
|
Manufacturer Contact |
brian
thompson
|
3800 east centre avenue |
portage, MI 49002
|
2693292100
|
|
MDR Report Key | 5676099 |
MDR Text Key | 45810865 |
Report Number | 0001831750-2016-00175 |
Device Sequence Number | 1 |
Product Code |
FMS
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
user facility |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
04/26/2016 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
No Information
|
Device Catalogue Number | FL19H |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
04/26/2016 |
Initial Date FDA Received | 05/24/2016 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 06/15/2016
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 01/06/2014 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
|
|