FDA Adverse Event
Other
Summary report: N
UNDETERMINED
MDR report key: 38017
·
Received September 13, 1996
Report
- Report Number
- 2125050-1996-00427
- Event Type
- Other
- Date Received
- September 13, 1996
- Date of Event
- August 9, 1996
- Report Date
- September 13, 1996
- Manufacturer
- UNDETERMINED
- Product Code
- FAE
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
NOTE: EVAL OF THIS OCCURRENCE IS THE RESPONSIBILITY OF THE PRODUCT MFR. ACCORDING TO THIS MFR'S PROCEDURES, ALL INFO CONCERNING THIS EVENT AND/OR THE DEVICE COMPONENTS REC'D HAVE BEEN RETURNED TO THE SENDER.
Description of Event or Problem · 1
UPON EXAMINATION OF THE DEVICE REC'D, IT WAS DETERMINED THAT THIS PROSTHESIS IS A NON-MENTOR MFG DEVICE. NOTE: DETERMINATION OF REPORTABILITY AND CATEGORIZATION OF THIS EVENT WAS MADE ACCORDING TO THIS MFR'S POLICIES AND PROCEDURES AND THE INFO REC'D IN COMPLIANCE WITH MED DEVICE REPORTING REGULATIONS. THESE DETERMINATIONS ARE NOT INTENDED TO EVALUATE THIS OCCURRENCE OR SUGGEST A CAUSE (REF SECTINS B2,B2 H1).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNDETERMINED Implant | PENILE PROSTHESIS | FAE | UNDETERMINED | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Required Intervention |