Brand Name | ISOLIBRIUM SUPPORT SURFACE - D |
Type of Device | BED, PATIENT ROTATION, 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 |
melanie
shepard
|
3800 east centre avenue |
portage, MI 49002
|
2693292100
|
|
MDR Report Key | 11217592 |
MDR Text Key | 228444599 |
Report Number | 0001831750-2021-00110 |
Device Sequence Number | 1 |
Product Code |
IKZ
|
UDI-Device Identifier | 07613327278453 |
UDI-Public | 07613327278453 |
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 |
01/22/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 01/22/2021 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
No Information
|
Device Model Number | 2972 |
Device Catalogue Number | 2972000000 |
Was Device Available for Evaluation? |
Yes
|
Date Manufacturer Received | 01/12/2021 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 08/28/2019 |
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 |
|
|