Brand Name | LOCALIZER |
Type of Device | MARKER, RADIOGRAPHIC, IMPLANTABLE |
Manufacturer (Section D) |
HEALTH BACONS, INC |
250 campus drive |
marlborough MA 01752 |
|
Manufacturer (Section G) |
RANFAC CORPORATION |
30 doherty avenue |
|
avon MA 02322 |
|
Manufacturer Contact |
sumanesh
agrawal
|
250 campus drive |
marlborough |
|
MDR Report Key | 12315848 |
MDR Text Key | 266301519 |
Report Number | 3013649990-2021-00006 |
Device Sequence Number | 1 |
Product Code |
NEU
|
UDI-Device Identifier | 00855436007037 |
UDI-Public | (01)00855436007037(11)210315 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K193189 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,user f |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
08/12/2021 |
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 |
Health Professional
|
Device Model Number | HB100 |
Was Device Available for Evaluation? |
Yes
|
Initial Date Manufacturer Received |
07/15/2021 |
Initial Date FDA Received | 08/12/2021 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 03/15/2021 |
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 |
Treatment | LOCALIZER TAG AND SURGICAL PROBE |
Patient Outcome(s) |
Other;
|