Brand Name | CAST CUTTER 230 V |
Type of Device | SAW, POWERED, AND ACCESSORIES |
Manufacturer (Section D) |
STRYKER INSTRUMENTS-KALAMAZOO |
4100 east milham avenue |
kalamazoo MI 49001 |
|
Manufacturer (Section G) |
STRYKER INSTRUMENTS-KALAMAZOO |
4100 east milham avenue |
|
kalamazoo MI 49001 |
|
Manufacturer Contact |
zach
baker
|
4100 east milham avenue |
kalamazoo, MI 49001
|
2693237700
|
|
MDR Report Key | 7201225 |
MDR Text Key | 97580047 |
Report Number | 0001811755-2018-00060 |
Device Sequence Number | 1 |
Product Code |
HAB
|
Combination Product (Y/N) | N |
Reporter Country Code | GB |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
HEALTH PROFESSIONAL |
Reporter Occupation |
|
Type of Report
| Initial,Followup |
Report Date |
09/28/2018 |
1 Device Was Involved in the Event |
|
1 Patient Was Involved in the Event | |
Date FDA Received | 01/17/2018 |
Is This An Adverse Event Report? |
Yes
|
Is This A Product Problem Report? |
No
|
Device Operator |
HEALTH PROFESSIONAL
|
Device Catalogue Number | 0941000000 |
Was Device Available For Evaluation? |
No
|
Is The Reporter A Health Professional? |
Yes
|
Was the Report Sent to FDA? |
|
Event Location |
No Information
|
Date Manufacturer Received | 09/20/2018 |
Was Device Evaluated By Manufacturer? |
Device Not Returned To Manufacturer
|
Date Device Manufactured | 04/23/2008 |
Is The Device Single Use? |
No
|
Is this a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient TREATMENT DATA |
Date Received: 01/17/2018 Patient Sequence Number: 1 |
|
|