MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-31 for AMS INFLATABLE PENILE PROSTHESIS UNK-P-IPP manufactured by Boston Scientific Corporation.
[185939749]
It was reported that the patient stated the pump was "agonizing" when trying to inflate an inflatable penile prosthesis (ipp) even trying to use numbing cream on it. The patient also indicated that the physician was aware of the problem. Product performance analyst (ppa) was unable to request further information, as customer contact for the account is unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183959-2020-01771 |
| MDR Report Key | 9908038 |
| Report Source | CONSUMER |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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 | 4083953452 |
| 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 | 1. Hospitalization; 2. Required No Informationntervention | 2020-03-31 |