Brand Name | AMS 650 MALLEABLE PENILE PROSTHESIS |
Type of Device | PROSTHESIS PENILE |
Manufacturer (Section D) |
BOSTON SCIENTIFIC CORPORATION |
300 boston scientific way |
marlborough MA 01752 |
|
Manufacturer (Section G) |
BOSTON SCIENTIFIC CORPORATION |
300 boston scientific way |
|
marlborough MA 01752 |
|
Manufacturer Contact |
alyson
harris
|
4100 hamline avenue north |
building c |
saint paul, MN 55112
|
|
MDR Report Key | 16463881 |
MDR Text Key | 310488557 |
Report Number | 2124215-2023-09665 |
Device Sequence Number | 1 |
Product Code |
FAE
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K951716 |
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 |
03/01/2023 |
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 | 01/12/2009 |
Device Model Number | 72401716 |
Device Catalogue Number | 72401716 |
Device Lot Number | 387037005 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
02/27/2023
|
Initial Date FDA Received | 03/01/2023 |
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) |
Hospitalization;
Required Intervention;
|
Patient Age | 72 YR |
Patient Sex | Male |