FDA Adverse Event
Death
Summary report: N
STYLE 168 SALINE FILLED BREAST IMPLANT
MDR report key: 1735706
·
Received June 23, 2010
Report
- Report Number
- 2024601-2010-00481
- Event Type
- Death
- Date Received
- June 23, 2010
- Date of Event
- June 1, 2007
- Report Date
- January 29, 2020
- Manufacturer
- ALLERGAN
- Product Code
- FWM
- PMA / PMN Number
- P990074
- Removal / Correction Number
- 2011068-7/2/19-001-R
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B) (4).
Additional Manufacturer Narrative · 1
THE EVENTS OF LYMPHADENOPATHY AND ABSCESS ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT.
Description of Event or Problem · 1
HEALTHCARE PROFESSIONAL REPORTS A DIAGNOSIS OF ALCL AND THE DEATH OF THIS PATIENT.
Description of Event or Problem · 1
HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED "DIFFUSE LYMPHADENOPATHY" AND "LEFT BREAST ABSCESS."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STYLE 168 SALINE FILLED BREAST IMPLANT | PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE | FWM | ALLERGAN | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Death | MISSING CONCOMITANT THERAPIES |