Brand Name | OBTRYX SYSTEM |
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) |
BOSTON SCIENTIFIC CORPORATION |
780 brookside drive |
|
spencer IN 47460 |
|
Manufacturer Contact |
farshad
fahimi
|
4100 hamline avenue north |
building c |
saint paul, MN 55112
|
|
MDR Report Key | 18859667 |
MDR Text Key | 337180686 |
Report Number | 2124215-2024-13529 |
Device Sequence Number | 1 |
Product Code |
OTN
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Foreign,Health Professional,Company Representative |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
03/07/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/07/2024 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 02/13/2024 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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 Outcome(s) |
Other;
|
|
|