Brand Name | UNIVERSAL MODULAR ELECTRIC/BATTERY SINGLE TRIGGER HANDPIECE |
Type of Device | UNIVERSAL MODULAR ELECTRIC/BATTERY SINGLETRIGGER HANDPIECE |
Manufacturer (Section D) |
ZIMMER SURGICAL SA |
3, ch. du pre fleuri |
plan-les-ouates, geneva 1228 |
SZ
1228
|
|
Manufacturer (Section G) |
ZIMMER SURGICAL SA |
3, ch. du pre fleuri |
plan-les-ouates |
plan-les-ouates, geneva 1228 |
SZ
1228
|
|
Manufacturer Contact |
christina
arnt
|
56 e. bell drive |
warsaw, IN 46582
|
5745273773
|
|
MDR Report Key | 10913793 |
MDR Text Key | 218510881 |
Report Number | 0008031000-2020-00010 |
Device Sequence Number | 1 |
Product Code |
HAB
|
Combination Product (Y/N) | N |
Reporter Country Code | KE |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
COMPANY REPRESENTATIVE,FOREIG |
Reporter Occupation |
|
Type of Report
| Initial |
Report Date |
11/27/2020 |
1 Device Was Involved in the Event |
|
1 Patient Was Involved in the Event | |
Date FDA Received | 11/27/2020 |
Is This An Adverse Event Report? |
Yes
|
Is This A Product Problem Report? |
Yes
|
Device Operator |
HEALTH PROFESSIONAL
|
Device Catalogue Number | 89-8507-400-10 |
Device LOT Number | 5008029 |
Was Device Available For Evaluation? |
No
|
Is The Reporter A Health Professional? |
|
Was the Report Sent to FDA? |
No
|
Event Location |
No Information
|
Date Manufacturer Received | 11/13/2020 |
Was Device Evaluated By Manufacturer? |
No
|
Date Device Manufactured | 04/12/2016 |
Is The Device Single Use? |
No
|
Is this a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
|
Patient TREATMENT DATA |
Date Received: 11/27/2020 Patient Sequence Number: 1 |
|
|