MAUDE Adverse Event Report: ZYRIS, INC. ISOLITE MOUTHPIECE.; ISOLITE MOUTHPIECE, MEDIUM DV CIL0801

Model Number CIL0801

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Code Available (3191)

Event Date 04/04/2019

Event Type  Injury  

Event Description

Dental patient received a blood blister in the interior of his left cheek from suction of the device due to misplacement of the device in the patient's mouth by the clinician.Clinician drained the blood blister to prevent the potential damage of the patient biting on it.No further intervention was necessary.

• Brand Name: ISOLITE MOUTHPIECE.
• Type of Device: ISOLITE MOUTHPIECE, MEDIUM DV CIL0801
• Manufacturer (Section D): ZYRIS, INC.; 6868a cortona drive; santa barbara CA 93117
• Manufacturer (Section G): ZYRIS, INC.; 6868a cortona dr.; santa barbara CA 93117
• Manufacturer Contact: morris sherwood ; 6868a cortona dr.; santa barbara, CA 93117 ; 8055609888
• MDR Report Key: 9182945
• MDR Text Key: 165958470
• Report Number: 2032574-2019-00001
• Device Sequence Number: 1
• Product Code: EIF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 06/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CIL0801
• Device Catalogue Number: CIL0801
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR