Brand Name | AMS SPECTRA CONCEALABLE PENILE PROSTHESIS |
Type of Device | PROSTHESIS PENILE |
Manufacturer (Section D) |
BOSTON SCIENTIFIC CORPORATION |
10700 bren road w |
minnetonka MN 55343 |
|
Manufacturer (Section G) |
BOSTON SCIENTIFIC CORPORATION |
10700 bren road w |
|
minnetonka MN 55343 |
|
Manufacturer Contact |
mike
bocchino
|
10700 bren road w |
minnetonka, MN 55343
|
6515827161
|
|
MDR Report Key | 8109049 |
MDR Text Key | 128558390 |
Report Number | 2183959-2018-61187 |
Device Sequence Number | 1 |
Product Code |
FAE
|
UDI-Device Identifier | 00878953005201 |
UDI-Public | 00878953005201 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K090663 |
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 |
11/27/2018 |
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? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Expiration Date | 04/16/2017 |
Device Model Number | 720054-01 |
Device Catalogue Number | 720054-01 |
Device Lot Number | 769758005 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
11/07/2018
|
Initial Date FDA Received | 11/27/2018 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 01/12/2011 |
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
|
Patient Age | 59 YR |