Brand Name | AMS INFLATABLE PENILE PROSTHESIS |
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 west |
|
minnetonka MN 55343 |
|
Manufacturer Contact |
alyson
harris
|
10700 bren road w |
minnetonka, MN 55343
|
4089353452
|
|
MDR Report Key | 8922921 |
MDR Text Key | 155273577 |
Report Number | 2183959-2019-65805 |
Device Sequence Number | 1 |
Product Code |
FHW
|
Combination Product (Y/N) | N |
Reporter Country Code | RO |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
FOREIGN,HEALTH PROFESSIONAL |
Reporter Occupation |
|
Type of Report
| Initial,Followup |
Report Date |
10/07/2019 |
1 Device Was Involved in the Event |
|
1 Patient Was Involved in the Event | |
Date FDA Received | 08/22/2019 |
Is This An Adverse Event Report? |
Yes
|
Is This A Product Problem Report? |
Yes
|
Device Operator |
LAY USER/PATIENT
|
Device MODEL Number | UNK-P-IPP |
Device Catalogue Number | UNK-P-IPP |
Was Device Available For Evaluation? |
Device Returned To Manufacturer
|
Date Returned to Manufacturer | 08/19/2019 |
Is The Reporter A Health Professional? |
Yes
|
Was the Report Sent to FDA? |
|
Event Location |
No Information
|
Date Manufacturer Received | 10/02/2019 |
Was Device Evaluated By Manufacturer? |
Yes
|
Is The Device Single Use? |
Yes
|
Is this a Reprocessed and Reused Single-Use Device? |
|
Type of Device Usage |
Initial
|