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 | 8515997 |
MDR Text Key | 141987723 |
Report Number | 2183959-2019-62255 |
Device Sequence Number | 1 |
Product Code |
FAE
|
Combination Product (y/n) | N |
Reporter Country Code | IN |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
04/15/2019 |
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 Model Number | UNK-P-SPP |
Device Catalogue Number | UNK-P-SPP |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
03/20/2019
|
Initial Date FDA Received | 04/15/2019 |
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) |
Hospitalization;
Required Intervention;
|
Patient Age | 56 YR |