MAUDE Adverse Event Report: EARLENS CORPORATION EARLENS IMPRESSION KIT

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.

• Brand Name: EARLENS IMPRESSION KIT
• Type of Device: IMPRESSION 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 Key: 6214578
• MDR Text Key: 63607726
• Report Number: 3010863048-2016-00002
• Device Sequence Number: 1
• Product Code: LDG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• 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 Received: 12/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2016
• 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 Sequence Number: 1
• Treatment: GENERAL ANESTHESIA
• Patient Outcome(s): Required Intervention