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 72404013 manufactured by Boston Scientific Corporation.
[185914776]
It was reported that the patient had previously had a coloplast device implanted. A revision surgery was scheduled at which time the cylinders were being replaced with bsc ipp cylinders. The first pair of bsc ipp cylinders were not used due to a measurement error. Another pair of cylinders were used to complete the surgery. There is no indication of a device malfunction or issue with the bsc ipp device. Additional information received clarified that the patient previously had a bsc inflatable penile prosthesis (ipp) device implanted. The cylinders of the ipp device were explanted due to pain. When implanting the new ipp device one pair of ipp cylinders were not used due to a measurement error. Another pair of cylinders were used to complete the surgery. There were no further patient complications for this case. Further additional information received states the pain was in the "glans penis. " no other treatments or interventions were tried to address the pain. The physician does not believe that the device caused or contributed to the pain. The patient was doing well following the surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183959-2020-01764 |
| MDR Report Key | 9908114 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-12 |
| Date Mfgr Received | 2020-03-17 |
| Device Manufacturer Date | 2019-03-14 |
| 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 | 72404013 |
| Catalog Number | 72404013 |
| Lot Number | 1000243038 |
| 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 |