FDA Adverse Event
Injury
Summary report: N
INFUSAID IMPLANTABLE INFUSION PUMP
MDR report key: 97143
·
Received June 10, 1997
Report
- Report Number
- 1219454-1997-00244
- Event Type
- Injury
- Date Received
- June 10, 1997
- Report Date
- May 13, 1997
- Manufacturer
- STRATO/INFUSAID, INC.
- Product Code
- MDY
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
ON 05/13/1997, THE MANUFACTURER RECEIVED A RESPONSE TO A DEVICE TRACKING POLLING LETTER FROM THE PATIENT. THE RESPONSE STATES THAT THE DEVICE WAS REMOVED ON MARCH 3RD DUE TO COMPLICATIONS.
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 | Required Intervention |