FDA Adverse Event
Injury
Summary report: N
PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
MDR report key: 17533195
·
Received August 12, 2023
Report
- Report Number
- MW5140099
- Event Type
- Injury
- Date Received
- August 12, 2023
- Report Date
- December 24, 2019
- Manufacturer
- UNKNOWN
- Product Code
- FTR
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
PATIENT'S MOTHER REPORTED THAT THE PATIENT'S CURRENT GEL DEVICES "LAY FLAT" AND HAVE "WRINKLES" AGAINST NON-ALLERGAN DEVICE. THIS IS FOR THE RIGHT SIDE. 2023342. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 784838 | PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED | PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED | FTR | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |