Brand Name | ULTRA COMFORT, SE 4 X 26 |
Type of Device | MATTRESS, FLOTATION THERAPY, NON-POWERED |
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 | 7893109 |
MDR Text Key | 120855757 |
Report Number | 0001831750-2018-01043 |
Device Sequence Number | 1 |
Product Code |
IKY
|
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 |
Report Date |
09/20/2018 |
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 | 1704034600 |
Was Device Available for Evaluation? |
Yes
|
Initial Date Manufacturer Received |
08/28/2018 |
Initial Date FDA Received | 09/20/2018 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 02/16/2018 |
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 |
|
|