FDA Adverse Event
Injury
Summary report: N
SYNCRHOMED EL
MDR report key: 1902274
·
Received November 15, 2010
Report
- Report Number
- 6000030-2010-09466
- Event Type
- Injury
- Date Received
- November 15, 2010
- Date of Event
- May 1, 2004
- Report Date
- October 29, 2010
- Manufacturer
- RICE CREEK MANUFACTURING
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT'S PUMP WAS REMOVED ON (B)(6) 2004, DUE TO A (B)(6) INFECTION. THERE WAS NO INFORMATION PROVIDED REGARDING THE TYPE, CONCENTRATION OR DOSAGE OF MEDICATION USED IN THE PATIENT'S PUMP. NO FURTHER DETAILS, PATIENT SYMPTOMS OR OUTCOME WERE PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT RECEIVED AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCRHOMED EL | LKK | RICE CREEK MANUFACTURING | 8626 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Required Intervention | IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8731, LOT# B009176N01 |