| Brand Name | XPRT MATTRESS W/O PENDANT |
|---|
| 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 |
|
kristen
canter
|
| 3800 east centre avenue |
| portage, MI 49002
|
|
2693292100
|
|
|---|
| MDR Report Key | 8249687 |
|---|
| MDR Text Key | 133126128 |
|---|
| Report Number | 0001831750-2019-00005 |
|---|
| 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,Followup |
|---|
| Report Date |
04/12/2019 |
|---|
| 1 Device was Involved in the Event |
|
| 1 Patient was Involved in the Event |
|
| Is this an Adverse Event Report? |
Yes
|
|---|
| Is this a Product Problem Report? |
Yes
|
|---|
| Device Operator |
No Information
|
|---|
| Device Catalogue Number | 2950200000 |
|---|
| Was Device Available for Evaluation? |
Yes
|
|---|
| Is the Reporter a Health Professional? |
No
|
|---|
| Initial Date Manufacturer Received |
12/20/2018
|
|---|
| Initial Date FDA Received | 01/15/2019 |
|---|
| Supplement Dates Manufacturer Received | 12/20/2018
|
|---|
| Supplement Dates FDA Received | 04/12/2019
|
|---|
| Was Device Evaluated by Manufacturer? |
Yes
|
|---|
| Date Device Manufactured | 11/07/2011 |
|---|
| 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 |
|---|
|
|
