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 WITH INHIBIZONE 72404233 manufactured by Boston Scientific Corporation.
[185914834]
It was reported that the patient began having a problem with the inflatable penile prosthesis in (b)(6) 2019 that he addressed with the physician, but no action was taken at that time. Eventual erosion into urethra was noted. The device was removed and the event resolved with no serious injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183959-2020-01755 |
| MDR Report Key | 9907976 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2019-11-01 |
| Date Mfgr Received | 2020-03-04 |
| Device Manufacturer Date | 2017-09-12 |
| 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 INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE |
| Generic Name | DEVICE IMPOTENCE MECHANICAL/HYDRAULIC |
| Product Code | FHW |
| Date Received | 2020-03-31 |
| Model Number | 72404233 |
| Catalog Number | 72404233 |
| Lot Number | 0185774005 |
| Device Expiration Date | 2019-08-24 |
| 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 | 1. Hospitalization; 2. Required No Informationntervention | 2020-03-31 |