• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EARLENS CORPORATION EARLENS IMPRESSION KIT

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

EARLENS CORPORATION EARLENS IMPRESSION KIT Back to Search Results
Device Problems Use of Device Problem (1670); Human-Device Interface Problem (2949)
Patient Problems Perforation (2001); Joint Dislocation (2374); Foreign Body In Patient (2687)
Event Date 12/02/2016
Event Type  Injury  
Manufacturer Narrative

Device not returned to manufacturer.

 
Event Description

The patient had bilateral sensorineural hearing impairment, and was fit monaurally with an earlens device on the right ear. The patient was very pleased with the performance of the earlens device and was very interested in exploring options to get earlens fitted in the left ear. The physician initially did not want to fit the patient with earlens on the left side as he had observed that the tympanic membrane on the left side appeared to have an abnormally thin area. In order to accommodate the patient request for an earlens device on the left side, the physician decided to repair the thinner area of the left tympanic membrane with a tympanoplasty. On (b)(6) 2016, the patient was placed under general anesthesia in preparation for performing the left tympanoplasty. Prior to the tympanoplasty, while under general anesthesia, the physician took an impression of the left ear canal with the earlens impression kit. The impression material was dispensed, cured and was removed by the physician. During the impression procedure, the physician noted bubbles emitting through the impression material. After the impression was removed, a perforation was observed in the tympanic membrane, and blue impression material was observed in the middle ear. In order to remove the impression material from the middle ear, the physician developed a tympanomeatal flap and surgically lifted the eardrum. During the procedure, the physician observed that impression material was also in the eustachian tube and appeared to have entered the mastoid area. Through a post auricular incision, the physician removed the mastoid cortex to explore the mastoid. The physician removed the impression material found in the mastoid. At the end of the procedure, the physician reported that he believed he had removed all of the impression material. During the process of removing the impression material from the middle ear and/or mastoid, the physician noted that the incus was separated from the stapes. The physician elected to repair the incus disarticulation with a partial ossicular replacement prosthesis (porp). In addition, the physician employed a cartilage graft to reinforce the thinner area of the tympanic membrane as well as the perforated area of the tympanic membrane. The tympanomeatal flap was repositioned to original anatomical configuration and the post auricular incision was closed.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameEARLENS IMPRESSION KIT
Type of DeviceIMPRESSION KIT
Manufacturer (Section D)
EARLENS CORPORATION
4045a campbell ave
menlo park CA 94025
Manufacturer (Section G)
EARLENS CORPORATION
4045a campbell ave
menlo park CA 94025
Manufacturer Contact
rasean hamilton
4045a campbell ave
menlo park, CA 94025
6507394427
MDR Report Key6214578
MDR Text Key63607726
Report Number3010863048-2016-00002
Device Sequence Number1
Product Code LDG
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial
Report Date 12/06/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/29/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/06/2016
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 TREATMENT DATA
Date Received: 12/29/2016 Patient Sequence Number: 1
Treatment
GENERAL ANESTHESIA
-
-