Brand Name | UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE TRIGGER HANDPIECE |
Type of Device | UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE TRIGGER HANDPIECE |
Manufacturer (Section D) |
ZIMMER SURGICAL SA |
chemin du pré fleuri, 3 |
plan-les-ouates, geneva CH-12 28 |
SZ
CH-1228
|
|
Manufacturer (Section G) |
ZIMMER SURGICAL SA |
chemin du pré fleuri, 3 |
|
plan-les-ouates, geneva CH-12 28 |
SZ
CH-1228
|
|
Manufacturer Contact |
christina
arnt
|
56 e. bell drive |
warsaw, IN 46582
|
5745273773
|
|
MDR Report Key | 8513469 |
MDR Text Key | 141903836 |
Report Number | 0008031000-2019-00014 |
Device Sequence Number | 1 |
Product Code |
HAB
|
Combination Product (Y/N) | N |
Reporter Country Code | FR |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
COMPANY REPRESENTATIVE,FOREIG |
Reporter Occupation |
OTHER HEALTH CARE PROFESSIONAL
|
Remedial Action |
Repair |
Type of Report
| Initial,Followup |
Report Date |
07/08/2019 |
1 Device Was Involved in the Event |
|
1 Patient Was Involved in the Event | |
Date FDA Received | 04/15/2019 |
Is This An Adverse Event Report? |
Yes
|
Is This A Product Problem Report? |
Yes
|
Device Operator |
HEALTH PROFESSIONAL
|
Device Catalogue Number | 89-8507-400-00 |
Device LOT Number | 5005618 |
Was Device Available For Evaluation? |
Device Returned To Manufacturer
|
Date Returned to Manufacturer | 05/14/2019 |
Is The Reporter A Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Event Location |
No Information
|
Date Manufacturer Received | 05/14/2019 |
Was Device Evaluated By Manufacturer? |
Yes
|
Date Device Manufactured | 12/11/2014 |
Is The Device Single Use? |
No
|
Is this a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unkown
|