FDA Adverse Event Injury Summary report: N

ISOVAC ADAPTER & MOUTHPIECE

MDR report key: 4181345 · Received September 9, 2014

Report

Report Number: 2032574-2014-00001
Event Type: Injury
Date Received: September 9, 2014
Date of Event: July 26, 2014
Report Date: September 2, 2014
Manufacturer: INNERLITE, INC. DBA ISOLITE SYSTEMS
Product Code: EIF
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

SINCE THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER, SOLITE SYSTEMS DOES NOT HAVE ENOUGH INFO TO DETERMINE THE ROOT CAUSE OF THIS ISSUE. AS SUCH, BASED ON THE INFO PROVIDED AND REVIEW OF ALL POST MARKETING SURVEILLANCE INFO TO DATE, ISOLITE SYSTEMS DOES NOT SEE A CAUSAL RELATIONSHIP BETWEEN THE ISOVAC/MOUTHPIECE AND THE PT SYMPTOMS REPORTED.

Description of Event or Problem · 1

DENTIST PERFORMED 15 MINUTE DENTAL FILLING PROCEDURE ON THE PT USING THE ISOVAC DEVICE (PART NUMBER EIV0101) AND LARGE MOUTHPIECE (PART NUMBER CIL0900) TO ISOLATE THE PORTION OF THE MOUTH BEING WORKED ON. IMMEDIATELY AFTER TREATMENT PT COMPLAINED OF SWELLING UNDER THE TONGUE. THE DOCTOR CONFIRMED THAT TISSUE WAS SWOLLEN. THE DOCTOR STATED HE ERRONEOUSLY USED TOO LARGE A MOUTHPIECE. DOCTOR STATED THAT PT APPEARED TO HAVE A TRAUMATIZED SALIVARY GLAND NEAR THE RANULA. DOCTOR SAID THAT TREATMENT AND INITIAL EVENT OCCURRED IN (B)(6). THE DOCTOR DID NOT NOTIFY ISOLITE SYSTEMS UNTIL (B)(4) 2014. THE DOCTOR ALSO STATED THAT THE SWELLING LASTED FOUR WEEKS AND THAT THE PT WAS GOING TO BE REFERRED TO AN ORAL SURGEON. SUBSEQUENT ATTEMPTS TO CONTACT THE DOCTOR TO GET STATUS UPDATE HAVE NOT BEEN SUCCESSFUL (DOCTOR NOT RESPONDING TO VOICE MALE/FEMALE).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
551706	ISOVAC ADAPTER & MOUTHPIECE	ISOVAC MOUTHPIECE	EIF	INNERLITE, INC. DBA ISOLITE SYSTEMS	CIL0900

Patients

Seq	Age	Sex	Outcome	Treatment
1	22 YR		Required Intervention