MAUDE Adverse Event Report: PRISMATIK DENTALCRAFT, INC. COMFORT HARD-SOFT SPLINT-UPPER; THERMOFORM MOUTHGUARD

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

The device has not been returned.If/when the device is returned an investigation will be carried out and a supplemental report will be submitted.Age or date of birth, sex, weight, ethnicity, race: the information was not provided when asked, with the exception of sex.Date of event: this information was not provided when asked.Is not applicable with the exception of serial number as the device is manufactured by prescription.Is not applicable as the device is manufactured by prescription and not implantable.

Event Description

The patient reports that the device "the appliance is breaking apart even more and now it's cutting his mouth.".

Manufacturer Narrative

A.1.-a.5.There was no patient involvement.H10: livanova deutschland manufactures the heater-cooler system 3t.The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate the device and could confirm the reported issue.In order to solve the issue, level float mechanism was cleaned and tank gasket replaced.Subsequent functional verification testing was completed without further issues and the unit was returned to service.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

• Brand Name: COMFORT HARD-SOFT SPLINT-UPPER
• Type of Device: THERMOFORM MOUTHGUARD
• Manufacturer (Section D): PRISMATIK DENTALCRAFT, INC.; 2301dupont drive; suite 250; irvine CA 92612
• Manufacturer (Section G): PRISMATIK DENTALCRAFT, INC.; 2301 dupont drive; suite 250; irvine CA 92612
• Manufacturer Contact: herbert schoenhoefer ; 2301 dupont drive; suite 250; irvine, CA 92612 ; 9494402532
• MDR Report Key: 12002259
• MDR Text Key: 258238995
• Report Number: 3011649314-2021-00218
• Device Sequence Number: 1
• Product Code: MQC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121365
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male