Brand Name | MYOSURE REACH TISSUE REMOVAL DEVICE |
Type of Device | HYSTEROSCOPE (AND ACCESSORIES) |
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 | 15999998 |
MDR Text Key | 305789901 |
Report Number | 1222780-2022-00395 |
Device Sequence Number | 1 |
Product Code |
HIH
|
UDI-Device Identifier | 15420045504530 |
UDI-Public | (01)15420045504530(17)250706(10)22G22RA |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K152723 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
User Facility,Company Representative |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial,Followup |
Report Date |
01/13/2023 |
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 Model Number | 10-401FC |
Device Catalogue Number | 10-401FC |
Device Lot Number | 2G22RA |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Initial Date Manufacturer Received |
11/30/2022
|
Initial Date FDA Received | 12/16/2022 |
Supplement Dates Manufacturer Received | 11/30/2022
|
Supplement Dates FDA Received | 01/13/2023
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 07/22/2022 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Sex | Female |