ADJUSTABLE HERBST APPLIANCE 0056G

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 2019-10-24 for ADJUSTABLE HERBST APPLIANCE 0056G manufactured by Dynaflex.

MAUDE Entry Details

• Report Number: 1937100-2019-00001
• MDR Report Key: 9233221
• Report Source: HEALTH PROFESSIONAL
• Date Received: 2019-10-24
• Date of Report: 2019-09-24
• Date of Event: 2018-05-06
• Date Mfgr Received: 2018-05-16
• Device Manufacturer Date: 2018-01-11
• Date Added to Maude: 2019-10-24
• 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: DENTIST
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MS MAUREEN MILLER
• Manufacturer Street: 10403 INTERNATIONAL PLAZA DRIV
• Manufacturer City: ST. ANN MO 63074
• Manufacturer Country: US
• Manufacturer Postal: 63074
• Manufacturer Phone: 3144264020
• Manufacturer G1: DYNAFLEX
• Manufacturer Street: 10403 INTERNATIONAL PLAZA DRIV
• Manufacturer City: ST. ANN MO 63074
• Manufacturer Country: US
• Manufacturer Postal Code: 63074
• Single Use: 3
• Remedial Action: RL
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ADJUSTABLE HERBST APPLIANCE
• Generic Name: ADJUSTABLE HERBST
• Product Code: LRK
• Date Received: 2019-10-24
• Model Number: 0056G
• Catalog Number: 0056G
• Lot Number: 748744
• Device Expiration Date: 2019-01-11
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: DYNAFLEX
• Manufacturer Address: 10403 INTERNATIONAL PLAZA DRIV ST. ANN MO 63074 US 63074

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2019-10-24