MAUDE Adverse Event Report: DYNAFLEX ADJUSTABLE HERBST SLEEP APPLIANCE

Model Number 00566

Device Problem Collapse (1099)

Patient Problems Discomfort (2330); Foreign Body In Patient (2687)

Event Date 04/01/2019

Event Type  Injury  

Manufacturer Narrative

Patient misuse of the product caused the problem.Wire mesh was added when the device was repaired to hold the acrylic tighter.

Event Description

Patient wearing adjustable herbst appliance was a grinder.He ground it until the acrylic broke off the metal.Arm was still attached but he swallowed a small piece of the device.No continuing medical problems occurred as a result but it was a choking hazard.

• Brand Name: ADJUSTABLE HERBST SLEEP APPLIANCE
• Type of Device: ADJUSTABLE HERBST
• Manufacturer (Section D): DYNAFLEX; 10403 intl plaza drive; st. ann MO 63074
• Manufacturer (Section G): DYNAFLEX; 10403 intl plaza drive; st. ann MO 63074
• Manufacturer Contact: maureen miller ; 10403 intl plaza drive; st. ann, MO 63074 ; 3144264020
• MDR Report Key: 9234256
• MDR Text Key: 168708284
• Report Number: 0001937100-2019-00005
• Device Sequence Number: 1
• Product Code: LRK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103076
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 09/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/22/2018
• Device Model Number: 00566
• Device Catalogue Number: 00566
• Device Lot Number: 661938
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/01/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/22/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 51 YR