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 2020-03-31 for AMS INFLATABLE PENILE PROSTHESIS 72404012 manufactured by Boston Scientific Corporation.
[185913759]
It was reported that the patient underwent a revision procedure due to the device not work properly that started two weeks prior to the revision procedure with an inflatable penile prosthesis (ipp). During the revision procedure the physician did testing and identified a leak in the left cylinder due to a puncture. The ipp cylinder was explanted and a new ipp cylinder was implanted. The patient recovered following the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183959-2020-01763 |
| MDR Report Key | 9907933 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-13 |
| Date Mfgr Received | 2020-03-16 |
| Device Manufacturer Date | 2012-12-17 |
| Date Added to Maude | 2020-03-31 |
| 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 INFLATABLE PENILE PROSTHESIS |
| Generic Name | DEVICE IMPOTENCE MECHANICAL/HYDRAULIC |
| Product Code | FHW |
| Date Received | 2020-03-31 |
| Model Number | 72404012 |
| Catalog Number | 72404012 |
| Lot Number | 802311001 |
| Device Expiration Date | 2017-11-21 |
| 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 | 2020-03-31 |