Brand Name | PASTE FILLER |
Type of Device | INSTRUMENT, FILLING, PLASTIC, DENTAL |
Manufacturer (Section D) |
DENTSPLY MAILLEFER |
chemin du verger 3 |
ballaigues, 1338 |
SZ 1338 |
|
Manufacturer (Section G) |
DENTSPLY MAILLEFER |
chemin du verger 3 |
|
ballaigues, 1338 |
SZ
1338
|
|
Manufacturer Contact |
helen
lewis
|
221 w. philadelphia st. |
suite 60w |
york, PA 17401
|
7178494229
|
|
MDR Report Key | 6373761 |
MDR Text Key | 69258446 |
Report Number | 8031010-2017-00010 |
Device Sequence Number | 1 |
Product Code |
EIY
|
Combination Product (y/n) | N |
Reporter Country Code | GM |
PMA/PMN Number | NA |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor,foreign |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
04/12/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | S206100440101 |
Device Lot Number | 1279419 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 01/31/2017 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
01/31/2017 |
Initial Date FDA Received | 03/02/2017 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 04/12/2017
|
Was Device Evaluated by Manufacturer? |
Yes
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
|
|