LIFENET UNOS #03-4508-004 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-09-13 for LIFENET UNOS #03-4508-004 * manufactured by *.

Event Text Entries

[18484447] The pt had an acl reconstruction of the right knee with a cadaver graft. A couple of days prior to admission pt was not feeling well, had some increased swelling and pain. Two days prior to admission, pt was put on duricef. On the day of admission, pt woke up with excruciating pain in the right knee and went to the dr's office. Pt was admitted and taken to surgery for incision and drainage; the graft was visualized and looked fine. Pt was subsequently discharged home the next day with order for iv rocephin. Cultures grew out serratia. The pt was readmitted the next day and had another incision and drainage the following day. Pt was discharged home the next day to continue on iv zosyn. Approx 40 hours prior to readmission on 15 days later, pt started to spike temperatures, but no knee pain. Of concern at that point was low white count of 1. 7. Pt picc line was examined with no evidence of any area of erythema or drainage. The infectious disease physician's impression was fever leukopenia, rule out bone marrow suppression secondary to the antiobiotic zosyn. Pt was subsequently discharged 2 days later, again on iv rocephin.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1033586
• MDR Report Key: 554174
• Date Received: 2004-09-13
• Date of Report: 2004-09-13
• Date of Event: 2004-08-09
• Date Added to Maude: 2004-11-12
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: LIFENET
• Generic Name: CADAVER GRAFT
• Product Code: LMO
• Date Received: 2004-09-13
• Model Number: UNOS #03-4508-004
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: N
• Implant Flag: Y
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 543802
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization	2004-09-13