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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INNERLITE, DBA ISOLITE SYSTEMS ISOLITE PEDIATRIC MOUTHPIECE
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INNERLITE, DBA ISOLITE SYSTEMS ISOLITE PEDIATRIC MOUTHPIECE Back to Search Results
Model Number CIL0501
Device Problem Use of Device Problem (1670)
Patient Problem Aspiration/Inhalation (1725)
Event Date 01/08/2015
Event Type  Injury  
Event Description
On (b)(6) 2015, the doctor was working on a (b)(6) patient under unconscious i.V.Sedation for fillings and crowns.The doctor was using an isolite pediatric size mouthpiece and had packed the patients throat with cotton as per standard dental protocol.The patient chair was in a fully reclined position.Approximately 10-15 minutes from the start of the procedure, the nurse anesthetist noticed that the patient was beginning to turn blue and the pulse ox monitor was dropping.She immediately alerted the doctor and they removed the mouthpiece and throat pack.The patients color and pulse returned to normal and they continued the procedure using a rubber dam with no further complications.
 
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Brand Name
ISOLITE PEDIATRIC MOUTHPIECE
Type of Device
PEDIATRIC MOUTHPIECE
Manufacturer (Section D)
INNERLITE, DBA ISOLITE SYSTEMS
6868a cortona dr.
santa barbara CA 93117
Manufacturer Contact
morris sherwood
6868a cortona dr.
santa barbara, CA 93117
8059689888
MDR Report Key4479321
MDR Text Key16882089
Report Number2032574-2015-00002
Device Sequence Number1
Product Code EIF
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Type of Report Initial
Report Date 01/15/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/21/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberCIL0501
Was Device Available for Evaluation? No
Date Manufacturer Received01/08/2015
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
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age5 YR
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