MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-17 for AMS SPECTRA CONCEALABLE PENILE PROSTHESIS 720074-03 manufactured by Boston Scientific Corporation.
[183751629]
It was reported that the patient had a removal of his inflatable penile prosthesis (ipp) due to scrotal pain. The ipp was replaced with a spectra malleable penile prosthesis (spp). During the case, when the doctor was about to implant the spp on the right side of the corpora, he noticed that there was missing part/piece of coating on the outside of the device (visible pieces of metal inside). Another device with different lot number was used to complete the procedure (one lot number on one side of the penis and another lot number on the other side). One of the device/rod (720074-03/120414004 left cylinder) was defective, while (720074-03/ 1000132285 right cylinder) was not defective. The procedure was completed and no patient complications were reported in relation to this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183959-2020-01320 |
| MDR Report Key | 9842617 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-02-25 |
| Date Mfgr Received | 2020-03-20 |
| Device Manufacturer Date | 2016-02-18 |
| Date Added to Maude | 2020-03-17 |
| 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 | 2020-03-17 |
| Returned To Mfg | 2020-03-05 |
| Model Number | 720074-03 |
| Catalog Number | 720074-03 |
| Lot Number | 0120414004 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-03-17 |