Brand Name | SIMPLEX P - CE ABC FD 10-PK |
Type of Device | BONE CEMENT, ANTIBIOTIC |
Manufacturer (Section D) |
STRYKER ORTHOPAEDICS-MAHWAH |
325 corporate drive |
mahwah NJ 07430 |
|
Manufacturer (Section G) |
STRYKER ORTHOPAEDICS-LIMERICK |
raheen business park |
|
limerick NA |
|
Manufacturer Contact |
joanne
mahony
|
ida industrial estate |
carrigtwohill NA
|
214532800
|
|
MDR Report Key | 8878696 |
MDR Text Key | 153818329 |
Report Number | 0002249697-2019-02778 |
Device Sequence Number | 1 |
Product Code |
MBB
|
Combination Product (y/n) | N |
Reporter Country Code | FR |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,other |
Reporter Occupation |
Pharmacist
|
Type of Report
| Initial |
Report Date |
08/09/2019 |
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? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 12/31/2020 |
Device Catalogue Number | 61969010 |
Device Lot Number | BDA009 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
08/07/2019 |
Initial Date FDA Received | 08/09/2019 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 02/01/2019 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Death;
Hospitalization;
Required Intervention;
|