MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-31 for AMS AMBICOR PENILE PROSTHESIS 72401450 manufactured by Boston Scientific Corporation.
[188481295]
It was reported that the during replacement procedure of another manufacturer device, the ambicor penile prosthesis (app) that they tried was malfunctioning, it would not pump completely.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 2183959-2020-01782 |
MDR Report Key | 9908261 |
Report Source | HEALTH PROFESSIONAL |
Date Received | 2020-03-31 |
Date of Report | 2020-03-31 |
Date of Event | 2020-03-17 |
Date Mfgr Received | 2020-03-17 |
Device Manufacturer Date | 2018-11-12 |
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 WEST |
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 AMBICOR PENILE PROSTHESIS |
Generic Name | DEVICE IMPOTENCE MECHANICAL/HYDRAULIC |
Product Code | FHW |
Date Received | 2020-03-31 |
Returned To Mfg | 2020-03-31 |
Model Number | 72401450 |
Catalog Number | 72401450 |
Lot Number | 1000190999 |
Operator | HEALTH PROFESSIONAL |
Device Availability | R |
Device Eval'ed by Mfgr | * |
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 |