FDA Adverse Event
Injury
Summary report: N
SYNCHROMED EL
MDR report key: 1872806
·
Received October 14, 2010
Report
- Report Number
- 6000030-2010-07949
- Event Type
- Injury
- Date Received
- October 14, 2010
- Date of Event
- September 1, 2010
- Report Date
- September 16, 2010
- Manufacturer
- RICE CREEK MANUFACTURING
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED AND INFECTION AT THE PUMP SITE. THE PUMP WAS SUBSEQUENTLY EXPLANTED. NO INFORMATION WAS PROVIDED REGARDING THE TYPE, CONCENTRATION OR DOSAGE OF THE 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 | SYNCHROMED EL | LKK | RICE CREEK MANUFACTURING | 8627L18 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Required Intervention | EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709, LOT #J11784R06 |