Brand Name | AMS ADVANCE MALE SLING SYSTEM |
Type of Device | MESH, SURGICAL, FOR STRESS URINARY INCONTINENCE, MALE |
Manufacturer (Section D) |
BOSTON SCIENTIFIC - MINNETONKA |
10700 bren road w |
minnetonka MN 55343 |
|
Manufacturer (Section G) |
BOSTON SCIENTIFIC - MINNETONKA |
10700 bren road w |
|
minnetonka MN 55343 |
|
Manufacturer Contact |
sharon
zurn
|
10700 bren road w |
minnetonka, MN 55343
|
9529306000
|
|
MDR Report Key | 7658078 |
MDR Text Key | 113003919 |
Report Number | 2183959-2018-00086 |
Device Sequence Number | 1 |
Product Code |
OTM
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | NA |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
06/14/2018 |
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 |
Lay User/Patient
|
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
06/19/2018 |
Initial Date FDA Received | 07/03/2018 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 82 YR |