FDA Adverse Event
Injury
Summary report: N
SYNCHORMED EL
MDR report key: 476401
·
Received August 4, 2003
Report
- Report Number
- 6000030-2003-00679
- Event Type
- Injury
- Date Received
- August 4, 2003
- Date of Event
- July 2, 2003
- Report Date
- July 8, 2003
- Manufacturer
- RICE CREEK MANUFACTURING
- Product Code
- LKK
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
HCP REPORTS PATIENT PRESENTED WITH SIGNS OF AN INFECTION IN THE PUMP POCKET INCLUDING FEVER, REDNESS, "FULLNESS" AROUND THE PUMP, AND PAIN. HCP REPORTS THE INFECTION WAS "SEEDED" FROM THE PATIENT'S URINARY TRACT INFECTION. CULTURES WERE TAKEN FROM THE PUMP POCKET. THE PUMP WAS EXPLANTED AND RETURNED TO THE MANUFACTURER FOR ANALYSIS. SURGERY FOR A RIGHT HUMERUS FRACTURE WAS DELAYED DUE TO THIS HOSPITALIZATION. THE PATIENT IS REPORTED AS HAVING RISK FACTOR OF HAVING A URINARY TRACT INFECTION. HCP REPORTED PATIENT WILL PROBABLY NOT BE RECEIVING ANOTHER PUMP AS PATIENT IS CURRENTLY PAIN FREE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHORMED EL | PUMP | LKK | RICE CREEK MANUFACTURING | 862718 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Other | CATHETER MODEL 8709 IMPLANTED 2002 EXPLANTED 2003. |