AMT MINI ONE? ENTERAL EXTENSION SET 8-2455-ISOSAF

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 2019-09-19 for AMT MINI ONE? ENTERAL EXTENSION SET 8-2455-ISOSAF manufactured by Applied Medical Technology, Inc..

MAUDE Entry Details

• Report Number: 1526012-2019-00002
• MDR Report Key: 9087973
• Report Source: HEALTH PROFESSIONAL
• Date Received: 2019-09-19
• Date of Report: 2019-09-16
• Date of Event: 2019-07-09
• Date Mfgr Received: 2019-08-26
• Date Added to Maude: 2019-09-19
• 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: SARAH BEERCHECK
• Manufacturer Street: 8006 KATHERINE BLVD.
• Manufacturer City: BRECKSVILE OH 44141
• Manufacturer Country: US
• Manufacturer Postal: 44141
• Manufacturer Phone: 4402622541
• Manufacturer G1: APPLIED MEDICAL TECHNOLOGY, INC
• Manufacturer Street: 8006 KATHERINE BLVD
• Manufacturer City: BRECKSVILLE OH 44141
• Manufacturer Country: US
• Manufacturer Postal Code: 44141
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: AMT MINI ONE? ENTERAL EXTENSION SET
• Generic Name: ENTERAL EXTENSION SET
• Product Code: PIF
• Date Received: 2019-09-19
• Returned To Mfg: 2019-07-22
• Model Number: 8-2455-ISOSAF
• Lot Number: 190604-016
• Operator: LAY USER/PATIENT
• Device Availability: R
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: APPLIED MEDICAL TECHNOLOGY, INC.
• Manufacturer Address: 8006 KATHERINE BLVD. BRECKSVILLE OH 44141 US 44141

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-09-19