MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-22 for AMS SPECTRA CONCEALABLE PENILE PROSTHESIS 720074-03 manufactured by Boston Scientific Corporation.
[180581050]
It was reported that after experiencing infection and proximal erosion with another company's penile prosthesis the patient underwent a surgical procedure in which a new spectra penile prosthesis (spp) was implanted. However, on a follow up appointment the physician noted the patient was experiencing distal erosion of one cylinder. It was mentioned that this did not come as a surprise as the patient had very poor tissue quality. A surgical procedure was performed in which both spp cylinders were removed. The patient did not experience any further complications. It was further reported that the erosion was identified due to the implant coming out of the patient's glans. However, physician does not believe the device caused the erosion. It was indicated that the previous company{s device likely caused pending erosion due to patient leaving it inflated for six years resulting in poor tissue quality. There were no device malfunctions associated with the explanted spp.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183959-2020-00208 |
| MDR Report Key | 9618130 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-01-22 |
| Date of Report | 2020-01-22 |
| Date of Event | 2020-01-07 |
| Date Mfgr Received | 2020-01-08 |
| Device Manufacturer Date | 2017-12-12 |
| Date Added to Maude | 2020-01-22 |
| 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 | 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 SPECTRA CONCEALABLE PENILE PROSTHESIS |
| Generic Name | PROSTHESIS PENILE |
| Product Code | FAE |
| Date Received | 2020-01-22 |
| Model Number | 720074-03 |
| Catalog Number | 720074-03 |
| Lot Number | 1000023096 |
| 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 | 2020-01-22 |