FDA Adverse Event
Malfunction
Summary report: N
V. MUELLER DIV. BAXTER HEALTHCARE CORP.
MDR report key: 18107
·
Received November 2, 1994
Report
- Report Number
- 18107
- Event Type
- Malfunction
- Date Received
- November 2, 1994
- Date of Event
- October 28, 1994
- Report Date
- November 2, 1994
- Manufacturer
- V. MUELLER DIV. BAXTER HEALTHCARE CORP.
- Product Code
- FTR
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MI, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
BREAST IMPLANTS REMOVED. PT HAVING MANY GENERAL MEDICAL TROUBLES INCLUDING ARTHRITIS. HOSPITAL HAS THE IMPLANTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | V. MUELLER DIV. BAXTER HEALTHCARE CORP. Implant | BREAST IMPLANT | FTR | V. MUELLER DIV. BAXTER HEALTHCARE CORP. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 * | Other |