MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-03-31 for AMS INFLATABLE PENILE PROSTHESIS UNK-P-IPP manufactured by Boston Scientific Corporation.
[188482178]
It was reported that the patient is scheduled for a future revision due to inflation issues and an absence of an erection with an inflatable penile prosthesis (ipp). The ipp remains implanted and active.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 2183959-2020-01762 |
MDR Report Key | 9907667 |
Report Source | FOREIGN,HEALTH PROFESSIONAL |
Date Received | 2020-03-31 |
Date of Report | 2020-03-31 |
Date of Event | 2020-03-11 |
Date Mfgr Received | 2020-03-11 |
Date Added to Maude | 2020-03-31 |
Event Key | 0 |
Report Source Code | Manufacturer report |
Manufacturer Link | Y |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 3 |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Contact | ALYSON HARRIS |
Manufacturer Street | 10700 BREN ROAD W |
Manufacturer City | MINNETONKA MN 55343 |
Manufacturer Country | US |
Manufacturer Postal | 55343 |
Manufacturer Phone | 4089353452 |
Manufacturer G1 | BOSTON SCIENTIFIC CORPORATION |
Manufacturer Street | 10700 BREN ROAD W |
Manufacturer City | MINNETONKA MN 55343 |
Manufacturer Country | US |
Manufacturer Postal Code | 55343 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | AMS INFLATABLE PENILE PROSTHESIS |
Generic Name | DEVICE IMPOTENCE MECHANICAL/HYDRAULIC |
Product Code | FHW |
Date Received | 2020-03-31 |
Model Number | UNK-P-IPP |
Catalog Number | UNK-P-IPP |
Operator | LAY USER/PATIENT |
Device Availability | N |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | BOSTON SCIENTIFIC CORPORATION |
Manufacturer Address | 10700 BREN ROAD W MINNETONKA MN 55343 US 55343 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2020-03-31 |