Brand Name | AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE |
Type of Device | DEVICE IMPOTENCE MECHANICAL/HYDRAULIC |
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 |
alyson
harris
|
10700 bren road w |
minnetonka, MN 55343
|
4089353452
|
|
MDR Report Key | 11223597 |
MDR Text Key | 228457508 |
Report Number | 2183959-2021-00134 |
Device Sequence Number | 1 |
Product Code |
FHW
|
UDI-Device Identifier | 00878953003597 |
UDI-Public | 00878953003597 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | N970012 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
01/25/2021 |
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 | 03/22/2021 |
Device Model Number | 72404251 |
Device Catalogue Number | 72404251 |
Device Lot Number | 1000250458 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
01/15/2021 |
Initial Date FDA Received | 01/25/2021 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 03/26/2019 |
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 | 60 YR |