MTS ANTI-HUMAN GLOBULIN POLYSPECIFIC ANTI-IGG,-C3D CARD MTS084014

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 2020-02-07 for MTS ANTI-HUMAN GLOBULIN POLYSPECIFIC ANTI-IGG,-C3D CARD MTS084014 manufactured by Microtyping Systems.

MAUDE Entry Details

• Report Number: 1056600-2020-00001
• MDR Report Key: 9682243
• Report Source: HEALTH PROFESSIONAL
• Date Received: 2020-02-07
• Date of Report: 2020-02-07
• Date of Event: 2020-01-28
• Date Mfgr Received: 2020-01-29
• Device Manufacturer Date: 2019-08-05
• Date Added to Maude: 2020-02-07
• 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: MR. JAMES A STEVENS
• Manufacturer Street: 1001 ROUTE 202
• Manufacturer City: RARITAN NJ 08869
• Manufacturer Country: US
• Manufacturer Postal: 08869
• Manufacturer Phone: 9082188223
• Manufacturer G1: MICROTYPING SYSTEMS
• Manufacturer Street: 1295 SOUTHWEST 29TH AVENUE
• Manufacturer City: POMPANO BEACH FL 33069
• Manufacturer Country: US
• Manufacturer Postal Code: 33069
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: MTS ANTI-HUMAN GLOBULIN POLYSPECIFIC ANTI-IGG,-C3D CARD
• Generic Name: MTS GEL CARDS- FOR DIRECT ANTIGLOBULIN TEST
• Product Code: KSZ
• Date Received: 2020-02-07
• Catalog Number: MTS084014
• Lot Number: 072419005-01
• Device Availability: Y
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MICROTYPING SYSTEMS
• Manufacturer Address: 1295 SOUTHWEST 29TH AVENUE POMPANO BEACH FL 33069 US 33069

Patients

Patient Number	Treatment	Outcome	Date
1	0		2020-02-07