FDA Adverse Event
Injury
Summary report: N
BREAST IMPLANTS
MDR report key: 20088485
·
Received August 27, 2024
Report
- Report Number
- MW5158892
- Event Type
- Injury
- Date Received
- August 27, 2024
- Date of Event
- January 9, 2021
- Report Date
- August 21, 2024
- Manufacturer
- UNK
- Product Code
- FTR
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- AS
- Reporter Occupation
- PATIENT
- Health Professional
- *
Narratives
Description of Event or Problem · 0
HTTPS://WWW.FDA.GOV/ABOUT-FDA/CONTACT-FDA I HAVE BEEN CHRONICALLY UNWELL WITHOUT DIAGNOSIS UNTIL NOW. I HAVE IMPLANTS DONE IN 2009. I HAVE NOW DEVELOPED VARIOUS CHRONIC HEALTH ISSUES LYMPHEDEMA, CYSTS EVERYWHERE AND EXCESSIVE CALCIFICATION AND PLAQUE. POOR BLOOD FLOW OXYGEN, NERVE COMPRESSION ECT. I WOULD LIKE TO SHARE WHAT I KNOW SO FAR I STILL HAVE THE BREAST IMPLANTS IN AND SEEKING FURTHER INFORMATION ON THE NEXT STEP. I HAVE VARIOUS MEDICAL EVIDENCE TO DATE. REFERENCE REPORT #: MW5158891.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1356130 | BREAST IMPLANTS | PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED | FTR | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR | Female | Other| H| S| L| R |