MAUDE Adverse Event Report: EARLENS CORPORATION EARLENS IMPRESSION KIT

Device Problem Human-Device Interface Problem (2949)

Patient Problem Perforation (2001)

Event Date 10/10/2016

Event Type  Injury  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

The patient was an (b)(6) male with multiple health issues and a lot of hearing loss.It was noted by the physician that the patient could not hear him very well and may not have heard the instructions not to move during the impression process.The physician successfully obtained an impression of the right ear before proceeding to the left ear.While the physician was dispensing impression material with the earlens impression equipment in the left ear, the patient moved suddenly and the mixing tip caused a perforation of the tympanic membrane.The perforation was observed by the physician upon removal of the impression material after approximately 10 minutes of cure time.It was also observed that a small amount of impression material passed through the perforation into the middle ear space.Besides the initial discomfort reported by the patient during the dispensing of the impression material, the patient did not report any pain.The physician believes that he may have contacted the patient with the dispensing tip on the ear canal wall or anterior bulge, which may have caused discomfort and caused the patient to move, which in turn perforated the tympanic membrane.The physician administered phenol, a local anesthetic, on the tympanic membrane, made a slightly larger incision at the point of the perforation, and removed the impression material from the middle ear in one piece.It was noted that the impression material was easily removed and that there was no impression material left in the middle ear space.The physician applied gel foam to the perforation.This event took place at the physician's office.

• 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: 6081124
• MDR Text Key: 59269532
• Report Number: 3010863048-2016-00001
• 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: 10/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 03/31/2017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/10/2016
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 89 YR