ALLOSOURCE *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-03-04 for ALLOSOURCE * manufactured by Allosource.

Event Text Entries

[16268960] Pt with failed t. H. A. Had revision surgery requiring bone grafting. Pt developed an infection with bacteroides fragilis cultured from wand. Pt had debridement surgery and has been dismissed to place of residence.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1034849
• MDR Report Key: 579945
• Date Received: 2005-03-04
• Date of Event: 2004-11-09
• Date Added to Maude: 2005-03-11
• 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
• 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 Sequence Number: 1

• Brand Name: ALLOSOURCE
• Generic Name: CANPAC
• Product Code: LMO
• Date Received: 2005-03-04
• Model Number: *
• Catalog Number: *
• Lot Number: 044366-103
• ID Number: *
• Device Availability: *
• Implant Flag: Y
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 569792
• Manufacturer: ALLOSOURCE
• Manufacturer Address: * * *

Device Sequence Number: 2

• Brand Name: ALLOSOURCE
• Generic Name: 24416100 (BONE PRODUCT - ALLOGRAFT)
• Product Code: LMO
• Date Received: 2005-03-04
• Model Number: *
• Catalog Number: *
• Lot Number: 044375-105
• ID Number: *
• Device Availability: *
• Device Age: *
• Implant Flag: Y
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 569793
• Manufacturer: ALLOSOURCE
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization	2005-03-04