FDA Adverse Event
Injury
Summary report: N
MEME
MDR report key: 395700
·
Received May 13, 2002
Report
- Report Number
- MW1025077
- Event Type
- Injury
- Date Received
- May 13, 2002
- Date of Event
- April 21, 2002
- Report Date
- May 13, 2002
- Manufacturer
- BRISTOL MYERS SQUIBB MANUFACTURING
- Product Code
- FTR
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
ADD'L INFO REC'D FROM PT 8/5/02: REPEAT BONE MARROW ASPIRATION AND BIOPSY.
Description of Event or Problem · 1
ADD'L INFO REC'D FROM MFR 6/20/02: PURSUANT TO TELEPHONE CONVERSATION OF 6/13/02, MFR OFFERS THE FOLLOWING INFO CONCERNING THE REPORT. EVENT FIRST REPORTED TO MFR 5/24/93 VIA LAWSUIT DOCUMENTS. EVENT REPORT TO FDA 5/25/93 AND ASSIGNED FDA ACCESS #M385392. ADDENDUM REPORT SENT TO FDA 6/14/99 REGARDING MEDWATCH REPORT #1016229. MEDICAL ENGINEERING CORP DOES NOT HAVE ANY FURTHER INFO CONCERNING THIS EVENT.
Description of Event or Problem · 1
PLASTIC SURGEON STATED THESE WERE SAFE AND ENDORCED BY THE FDA AS SAFE. HAD TO HAVE ONE REPLACED, IT WAS INFECTED WITH STAPH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MEME | SILICONE/POLYURETHANE BREAST IMPLANT | FTR | BRISTOL MYERS SQUIBB MANUFACTURING | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Life Threatening| S |