MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-30 for AMS SPECTRA CONCEALABLE PENILE PROSTHESIS 720056-02 manufactured by Boston Scientific Corporation.
[186676409]
As the complaint component was not returned for analysis, and the product record review revealed no additional information related to the complaint, the reported allegation could not be confirmed. The event cannot be reproduced or substantiated.
Patient Sequence No: 1, Text Type: N, H10
[186676410]
It was reported that the patient's spectra penile prosthesis (spp) was removed due to unknown reason. A new spp was implanted in the right side only. No information about the patient's outcome was provided. Additional information received. The patient presented a small hole with drainage on the lateral aspect of his penis. There was no cylinder in the left side due to scarring in left corporal body. No device malfunction with previous spp.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183959-2020-01678 |
| MDR Report Key | 9897112 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-30 |
| Date of Report | 2020-04-01 |
| Date of Event | 2020-03-02 |
| Date Mfgr Received | 2020-03-09 |
| Device Manufacturer Date | 2017-07-31 |
| Date Added to Maude | 2020-03-30 |
| 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 | 2020-03-30 |
| Model Number | 720056-02 |
| Catalog Number | 720056-02 |
| Lot Number | 0183201005 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| 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 | 2020-03-30 |