FDA Adverse Event
Injury
Summary report: N
UNK SALINE IMPLANT
MDR report key: 17214073
·
Received June 27, 2023
Report
- Report Number
- 9617229-2023-10668
- Event Type
- Injury
- Date Received
- June 27, 2023
- Date of Event
- January 1, 2010
- Report Date
- June 27, 2023
- Manufacturer
- ALLERGAN (COSTA RICA)
- Product Code
- FWM
- PMA / PMN Number
- P990074
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
ARTICLE CITATION: ROSENBERG K, MCGILLEN P, ZANFAGNIN V, ET AL. INVASIVE SQUAMOUS CELL CARCINOMA OF THE BREAST ASSOCIATED WITH BREAST AUGMENTATION IMPLANT CAPSULE. J SURG ONCOL. 2023;1-7. DOI:10.1002/JSO.27364. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. REASON FOR REOPERATION: "RUPTURE."
Description of Event or Problem · 0
THROUGH THE ARTICLE, "INVASIVE SQUAMOUS CELL CARCINOMA OF THE BREAST WITH BREAST AUGMENTATION IMPLANT CAPSULE," HEALTHCARE PROFESSIONAL REPORTED A PATIENT UNDERWENT BREAST AUGMENTATION WITH SUBPECTORAL SALINE IMPLANTS AND EXPERIENCED A LEFT IMPLANT RUPTURE. DEVICE WAS EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 120415 | UNK SALINE IMPLANT | PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE | FWM | ALLERGAN (COSTA RICA) | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Female | Required Intervention |