FMC CASSETTE UNKNOWN- FMC CASSETTE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2020-03-27 for FMC CASSETTE UNKNOWN- FMC CASSETTE manufactured by Erika De Reynosa, S.a. De C.v..

MAUDE Entry Details

• Report Number: 8030665-2020-00365
• MDR Report Key: 9891580
• Report Source: COMPANY REPRESENTATIVE,CONSUM
• Date Received: 2020-03-27
• Date of Report: 2020-03-27
• Date of Event: 2020-03-06
• Date Mfgr Received: 2020-03-13
• Date Added to Maude: 2020-03-27
• 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
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MATTHEW AMARAL
• Manufacturer Street: 920 WINTER ST
• Manufacturer City: WALTHAM MA 02451
• Manufacturer Country: US
• Manufacturer Postal: 02451
• Manufacturer Phone: 7816999758
• Manufacturer G1: ERIKA DE REYNOSA, S.A. DE C.V.
• Manufacturer Street: DIRECTOR, QUALITY SYSTEMS 1100 E, MILITARY HWY, SUITE C
• Manufacturer City: PHARR TX 78577
• Manufacturer Country: US
• Manufacturer Postal Code: 78577
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: FMC CASSETTE
• Generic Name: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Product Code: FKX
• Date Received: 2020-03-27
• Model Number: UNKNOWN- FMC CASSETTE
• Catalog Number: UNKNOWN- FMC CASSETTE
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Age: MO
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ERIKA DE REYNOSA, S.A. DE C.V.
• Manufacturer Address: MIKE ALLEN #1331 PARQUE INDUSTRIAL REYNOSA REYNOSA 88780 MX 88780

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Required No Informationntervention	2020-03-27