FDA Adverse Event
Injury
Summary report: N
COX-UPHOFF INTERNATIONAL
MDR report key: 1160908
·
Received September 12, 2008
Report
- Report Number
- MW5008292
- Event Type
- Injury
- Date Received
- September 12, 2008
- Report Date
- September 12, 2008
- Manufacturer
- UNK
- Product Code
- FWM
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- SC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IN 1987, BILATERAL BREAST AUGMENTATION WITH MASTOPEXY - NOW HAS BILATERAL PTOSIS AND IS UNHAPPY WITH APPEARANCE. IN 2008, PT UNDERWENT BILATERAL IMPLANT REMOVAL AND BILATERAL AUGMENTATION WITH MASTOPEXY. OLD IMPLANTS REMOVED INTACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COX-UPHOFF INTERNATIONAL | SALINE/GEL IMPLANTS - BREAST | FWM | UNK | RTM340641 | ||
| 2 | COX-UPHOFF INTERNATIONAL | SALINE/GEL IMPLANTS - BREAST | FWM | UNK | LTM310810 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Other |