Brand Name | INVISALIGN CLEANING CRYSTALS |
Type of Device | CLEANSER, DENTURE, OVER THE COUNTER |
Manufacturer (Section D) |
ALIGN TECHNOLOGY, INC. |
2820 orchard parkway |
san jose CA 95134 |
|
Manufacturer (Section G) |
ALIGN TECHNOLOGY, INC. |
2820 orchard parkway |
|
san jose CA 95134 |
|
Manufacturer Contact |
harper
shore
|
3030 slater rd |
morrisville, NC 27560
|
4084701343
|
|
MDR Report Key | 17916537 |
MDR Text Key | 325443770 |
Report Number | 2953749-2023-02897 |
Device Sequence Number | 1 |
Product Code |
EFT
|
UDI-Device Identifier | 00816063021407 |
UDI-Public | (01)00816063021407 |
Combination Product (y/n) | N |
Reporter Country Code | SP |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional |
Reporter Occupation |
Dentist
|
Type of Report
| Initial |
Report Date |
10/11/2023 |
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 |
Lay User/Patient
|
Device Model Number | INVISALIGN CLEANING CRYSTALS |
Device Catalogue Number | 20127 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
09/19/2023
|
Initial Date FDA Received | 10/11/2023 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Hospitalization;
|
Patient Age | 42 YR |
Patient Sex | Male |