MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-05 for AMS SPECTRA CONCEALABLE PENILE PROSTHESIS 720074-02 manufactured by Boston Scientific Corporation.
[177774802]
It was reported that during replacement procedure of an inflatable penile prosthesis (ipp) device, a spectra penile prosthesis (spp) cylinder cracked so it was replaced with a new spp device. No adverse patient effects. Additional information was receive. Device outer layer cracked while being manipulated into the patient. Physician believes it cracked while bending to insert into patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183959-2020-00440 |
| MDR Report Key | 9670465 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-02-05 |
| Date of Report | 2020-02-05 |
| Date of Event | 2020-01-15 |
| Date Mfgr Received | 2020-01-15 |
| Device Manufacturer Date | 2017-03-17 |
| Date Added to Maude | 2020-02-05 |
| 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 | AMERICAN MEDICAL SYSTEMS LLC |
| Manufacturer Street | 10700 BREN ROAD WEST |
| 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 | 2020-02-05 |
| Model Number | 720074-02 |
| Catalog Number | 720074-02 |
| Lot Number | 0170503001 |
| 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 | 2020-02-05 |