FDA Adverse Event
Death
Summary report: N
INFUSAID IMPLANTABLE INFUSION PUMP
MDR report key: 97924
·
Received June 13, 1997
Report
- Report Number
- 1219454-1997-00285
- Event Type
- Death
- Date Received
- June 13, 1997
- Date of Event
- May 1, 1997
- Report Date
- June 6, 1997
- Manufacturer
- STRATO/INFUSAID, INC.
- Product Code
- MDY
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
Narratives
Description of Event or Problem · 1
ON 06/06/1997, THE MANUFACTURER RECEIVED A RESPONSE TO A DEVICE TRACKING POLLING LETTER FROM THE PATIENT'S SON WHICH STATES THAT THE DEVICE DIDN'T WORK AND THAT NOTHING WORKS AGAINST CANCER. THE PATIENT REPORTEDLY EXPIRED ABOUT ONE MONTH AGO (05/97). THE PATIENT'S SON WOULD NOT PROVIDE HIS NAME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INFUSAID IMPLANTABLE INFUSION PUMP Implant | IMPLANTABLE INFUSION PUMP | MDY | STRATO/INFUSAID, INC. | 400 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Death |