Brand Name | OBTRYX SYSTEM - HALO |
Type of Device | MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR |
Manufacturer (Section D) |
BOSTON SCIENTIFIC CORPORATION |
300 boston scientific way |
marlborough MA 01752 |
|
Manufacturer (Section G) |
FREUDENBERG MEDICAL MIS INC |
2301 centennial boulevard |
|
jeffersonville IN 47130 |
|
Manufacturer Contact |
carole
morley
|
300 boston scientific way |
marlborough, MA 01752
|
5086834015
|
|
MDR Report Key | 11175545 |
MDR Text Key | 227016667 |
Report Number | 3005099803-2020-06712 |
Device Sequence Number | 1 |
Product Code |
OTN
|
UDI-Device Identifier | 08714729718987 |
UDI-Public | 08714729718987 |
Combination Product (y/n) | N |
Reporter Country Code | AS |
PMA/PMN Number | K040787 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Foreign,Consumer,Company Representative |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
10/17/2022 |
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 Expiration Date | 08/31/2014 |
Device Model Number | M0068505000 |
Device Catalogue Number | 850-500 |
Device Lot Number | ML00000290 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
12/16/2020
|
Initial Date FDA Received | 01/14/2021 |
Supplement Dates Manufacturer Received | 09/22/2022
|
Supplement Dates FDA Received | 10/17/2022
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 09/27/2011 |
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
Patient Age | 56 YR |
Patient Sex | Female |
|
|