ABBOTT PRISM HBSAG CONFIRMATORY ASSAY 06E51-68

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2019-07-11 for ABBOTT PRISM HBSAG CONFIRMATORY ASSAY 06E51-68 manufactured by Abbott Laboratories.

MAUDE Entry Details

• Report Number: 1415939-2019-00142
• MDR Report Key: 8781729
• Report Source: FOREIGN,HEALTH PROFESSIONAL
• Date Received: 2019-07-11
• Date of Report: 2019-08-13
• Date Mfgr Received: 2019-08-08
• Device Manufacturer Date: 2018-12-01
• Date Added to Maude: 2019-07-11
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• 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: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: CHRISTIAN LEE
• Manufacturer Street: 100 ABBOTT PARK ROAD DEPT 09B9, BLDG CP01-3
• Manufacturer City: ABBOTT PARK IL 600643537
• Manufacturer Country: US
• Manufacturer Postal: 600643537
• Manufacturer Phone: 224668-294
• Manufacturer G1: ABBOTT LABORATORIES
• Manufacturer Street: 100 ABBOTT PARK ROAD
• Manufacturer City: ABBOTT PARK IL 600643500
• Manufacturer Country: US
• Manufacturer Postal Code: 600643500
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ABBOTT PRISM HBSAG CONFIRMATORY ASSAY
• Generic Name: HBSAG
• Product Code: KSJ
• Date Received: 2019-07-11
• Catalog Number: 06E51-68
• Lot Number: 96011M500
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: DA
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ABBOTT LABORATORIES
• Manufacturer Address: 100 ABBOTT PARK ROAD ABBOTT PARK IL 600643500 US 600643500

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-07-11