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 2020-02-19 for TACTRA MALLEABLE PENILE PROTHESIS 720080-01 manufactured by Boston Scientific Corporation.
[180584301]
It was reported that the patient implanted with this tactra malleable penile prosthesis experienced necrosis of the glans penis. The patient is scheduled to undergo a surgical procedure to remove the necrotic tissue. No additional adverse patient effects were reported. Additional information was received indicating approximately 20 percent of the glans penis was necrosed and will be removed on an unspecified date. The physician intends to leave the malleable prosthesis implanted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183959-2020-00752 |
| MDR Report Key | 9729065 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-02-19 |
| Date of Report | 2020-03-05 |
| Date of Event | 2019-12-03 |
| Date Mfgr Received | 2020-03-05 |
| Device Manufacturer Date | 2019-09-13 |
| Date Added to Maude | 2020-02-19 |
| 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 | CASHEL ROAD |
| Manufacturer City | CLONMEL |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TACTRA MALLEABLE PENILE PROTHESIS |
| Generic Name | PROSTHESIS PENILE |
| Product Code | FAE |
| Date Received | 2020-02-19 |
| Model Number | 720080-01 |
| Catalog Number | 720080-01 |
| Lot Number | 0024519449 |
| 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. Other; 2. Required No Informationntervention | 2020-02-19 |