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 2020-03-20 for AMS SPECTRA CONCEALABLE PENILE PROSTHESIS 720056-02 manufactured by Boston Scientific Corporation.
[184324282]
It was reported that the spectra penile prosthesis (spp) device is going to be revised due to an infection. The patient "currently has a prosthesis-associated infection. The condition was confirmed with an ultrasound exam, which showed collection and inflammation, with drug treatment, the case was almost completely reversed, but requires surgical treatment. The proposed surgery is rescue surgery, trying to avoid the loss of the penile prosthesis, the patient is hospitalized receiving antibiotics and will be submitted to penile prosthesis rescue surgery on february 23rd. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183959-2020-01449 |
| MDR Report Key | 9860963 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-20 |
| Date of Event | 2020-01-01 |
| Date Mfgr Received | 2020-02-21 |
| Device Manufacturer Date | 2017-09-12 |
| Date Added to Maude | 2020-03-20 |
| 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 | 2020-03-20 |
| Model Number | 720056-02 |
| Catalog Number | 720056-02 |
| Lot Number | 0187040001 |
| 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 | 2020-03-20 |