FDA Adverse Event
Injury
Summary report: N
MENTOR
MDR report key: 289500
·
Received July 27, 2000
Report
- Report Number
- MW1019545
- Event Type
- Injury
- Date Received
- July 27, 2000
- Date of Event
- November 14, 1997
- Report Date
- July 14, 2000
- Manufacturer
- MENTOR
- Product Code
- FTR
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
"S/P B SUBMUSC SALINE IMPLANTS FOR CORRECTION OF INVOLUTIONAL PTOSIS. NO RECORDS TO CONFIRM C/O L BEING SMALLER FROM THE BEGINNING. DENIES DECREASED SIZE BUT THEY ARE MORE DROOPY. DENIES CHANGED TEXTURE OR H/O TRAUMA BUT ABOUT 14 MOS AGO DEVELOPED SEVERE PAIN L GREATER THAN R, INTERMITTENT. IT IS NOW RESOLVED X 2-4 MOS ? ETIOLOGY. PT HAS SOME MILD SYSTEMIC SX'S FOR YRS INCLUDING ARTHRALGIAS (+ AM STIFFNESS)/MYALGIAS, PARESTHESIAS/DYSESTHESIAS, FATIGUE, SPASMS, SLEEP DISTURB, HOT FLASHES/SWEATS, HEADACHES, DIZZINESS, MEMORY PROBS, SOB, WGT FLUCTUATIONS, NAUSEA, AND EASY BRUISING. PT IS OTHERWISE HEALTHY."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MENTOR | GEL BREAST IMPLANTS | FTR | MENTOR | NA | 8018 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Other| S |