FDA Adverse Event
Malfunction
Summary report: N
AMS 700 CX MS PUMP
MDR report key: 11777640
·
Received May 5, 2021
Report
- Report Number
- 2124215-2021-12553
- Event Type
- Malfunction
- Date Received
- May 5, 2021
- Date of Event
- April 1, 2021
- Report Date
- May 14, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- JCW
- UDI-DI
- 00878953003450
- PMA / PMN Number
- N970012
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 1
DATE OF EVENT: UNKNOWN, USED THE FIRST DATE OF THE AWARE MONTH.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT IS REQUESTING A REVISION OF AN INFLATABLE PENILE PROTHESIS(IPP) DUE TO THE DEVICE FAILING TO REMAIN INFLATED AND PREVENTING SEXUAL INTERCOURSE. THE IPP WAS TESTED IN THE OFFICE AND THE DEFECT WAS CONFIRMED. A PATIENT OUTCOME OF STABLE WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 237150 | AMS 700 CX MS PUMP | PROSTHESIS, PENIS, INFLATABLE | JCW | BOSTON SCIENTIFIC CORPORATION | 72404232 | 0163641002 | 00878953003450 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Male |