PICCOLO RENAL FUNCTION PANEL 400-0027

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-10-18 for PICCOLO RENAL FUNCTION PANEL 400-0027 manufactured by Abaxis, Inc..

MAUDE Entry Details

• Report Number: 2939693-2019-00002
• MDR Report Key: 9211011
• Report Source: HEALTH PROFESSIONAL
• Date Received: 2019-10-18
• Date of Report: 2019-10-17
• Date of Event: 2019-07-02
• Date Mfgr Received: 2019-08-15
• Device Manufacturer Date: 2019-04-23
• Date Added to Maude: 2019-10-18
• 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: MS. RONI THEBO
• Manufacturer Street: 3240 WHIPPLE RD
• Manufacturer City: UNION CITY CA 94587
• Manufacturer Country: US
• Manufacturer Postal: 94587
• Manufacturer Phone: 2693599544
• Manufacturer G1: ABAXIS, INC.
• Manufacturer Street: 3240 WHIPPLE ROAD
• Manufacturer City: UNION CITY CA 94587
• Manufacturer Country: US
• Manufacturer Postal Code: 94587
• Single Use: 3
• Previous Use Code: 3
• Removal Correction Number: N/A
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: PICCOLO RENAL FUNCTION PANEL
• Generic Name: PICCOLO RENAL PANEL
• Product Code: CEM
• Date Received: 2019-10-18
• Model Number: 400-0027
• Catalog Number: 400-0027
• Lot Number: 9172AC5
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ABAXIS, INC.
• Manufacturer Address: 3240 WHIPPLE ROAD UNION CITY CA 94587 US 94587

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2019-10-18