Brand Name | AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE |
Type of Device | DEVICE IMPOTENCE MECHANICAL/HYDRAULIC |
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 |
john
stoffregen
|
4100 hamline avenue north |
building c |
saint paul, MN 55112
|
|
MDR Report Key | 16984307 |
MDR Text Key | 315772846 |
Report Number | 2124215-2023-25476 |
Device Sequence Number | 1 |
Product Code |
FHW
|
UDI-Device Identifier | 00878953003597 |
UDI-Public | 00878953003597 |
Combination Product (y/n) | Y |
Reporter Country Code | RS |
PMA/PMN Number | N970012 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Foreign,Health Professional,Distributor |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
06/22/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 05/23/2023 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Expiration Date | 10/10/2021 |
Device Model Number | 72404251 |
Device Catalogue Number | 72404251 |
Device Lot Number | 1000343135 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 06/05/2023 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 10/11/2019 |
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 |
Treatment | RESERVOIR MODEL#72404156 LOT#1000316432; RESERVOIR MODEL#72404156 LOT#1000316432 |
Patient Outcome(s) |
Required Intervention;
Hospitalization;
|