Brand Name | ISOTOUR, 84 INCH,STD, END406 |
Type of Device | MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE |
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 |
melissa
simon
|
3800 east centre avenue |
portage, MI 49002
|
2693292100
|
|
MDR Report Key | 18222451 |
MDR Text Key | 329193067 |
Report Number | 0001831750-2023-01349 |
Device Sequence Number | 1 |
Product Code |
FNM
|
UDI-Device Identifier | 07613327424638 |
UDI-Public | 07613327424638 |
Combination Product (y/n) | N |
Reporter Country Code | CA |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Company Representative |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
03/29/2024 |
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 Catalogue Number | 2872000012 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
11/02/2023
|
Initial Date FDA Received | 11/28/2023 |
Supplement Dates Manufacturer Received | 11/02/2023
|
Supplement Dates FDA Received | 03/29/2024
|
Was Device Evaluated by Manufacturer? |
No
|
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 |
Patient Outcome(s) |
Other;
|
|
|