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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EARLENS CORPORATION EARLENS IMPRESSION KIT

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EARLENS CORPORATION EARLENS IMPRESSION KIT Back to Search Results
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.

 
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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 Key6081124
MDR Text Key59269532
Report Number3010863048-2016-00001
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 10/10/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/07/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator
Device EXPIRATION Date03/31/2017
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 Received10/10/2016
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 TREATMENT DATA
Date Received: 11/07/2016 Patient Sequence Number: 1
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