Brand Name | NOVASURE V5 |
Type of Device | DEVICE, THERMAL ABLATION, ENDOMETRIAL |
Manufacturer (Section D) |
HOLOGIC, INC |
250 campus drive |
marlborough MA 01752 |
|
Manufacturer (Section G) |
HOLOGIC, INC. |
250 campus drive |
|
marlborough MA 01752 |
|
Manufacturer Contact |
ariel
lafuente
|
562 parkway |
coyol free zone building b24 |
san jose 20102
|
|
MDR Report Key | 16864811 |
MDR Text Key | 314507696 |
Report Number | 1222780-2023-00153 |
Device Sequence Number | 1 |
Product Code |
HIH
|
UDI-Device Identifier | 15420045514294 |
UDI-Public | (01)15420045514294(17)250131(10)23A12R |
Combination Product (y/n) | N |
Reporter Country Code | CA |
PMA/PMN Number | P010013 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,User Facility,Company Representative |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial,Followup,Followup |
Report Date |
06/19/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 05/03/2023 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | V5 |
Device Catalogue Number | NSV5KITUS-001 |
Device Lot Number | 23A12R |
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 04/26/2023 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 01/01/2023 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
Required Intervention;
|
Patient Sex | Female |