MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-03 for AMS SPECTRA CONCEALABLE PENILE PROSTHESIS 720074-03 manufactured by Boston Scientific Corporation.
[177352961]
As the complaint component was not returned for analysis, and the product record review revealed no additional information related to the complaint. The reported allegations could not be confirmed. The event cannot be reproduced or substantiated; therefore, no escalation to ncep, capa or scar is required.
Patient Sequence No: 1, Text Type: N, H10
[177352962]
It was reported that the patient was admitted to hospital with one cylinder eroded and visible at meatus. Patient is demented, so no information available about when this first happened. Physician was able to remove cylinder with a clamp. No surgical intervention. The contralateral cylinder of the spectra penile prosthesis remains. No further complications were reported in relation to this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183959-2020-00388 |
| MDR Report Key | 9659123 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-02-03 |
| Date of Report | 2020-02-03 |
| Date of Event | 2020-01-13 |
| Date Mfgr Received | 2020-01-13 |
| Device Manufacturer Date | 2009-06-04 |
| Date Added to Maude | 2020-02-03 |
| 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 SPECTRA CONCEALABLE PENILE PROSTHESIS |
| Generic Name | PROSTHESIS PENILE |
| Product Code | FAE |
| Date Received | 2020-02-03 |
| Model Number | 720074-03 |
| Catalog Number | 720074-03 |
| Lot Number | 598718008 |
| Device Expiration Date | 2014-05-21 |
| 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 | 2020-02-03 |