MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-11-07 for EARLENS IMPRESSION KIT manufactured by Earlens Corporation.
[59269532]
Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[59269533]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010863048-2016-00001 |
| MDR Report Key | 6081124 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-11-07 |
| Date of Report | 2016-10-10 |
| Date of Event | 2016-10-10 |
| Date Mfgr Received | 2016-10-10 |
| Date Added to Maude | 2016-11-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS RASEAN HAMILTON |
| Manufacturer Street | 4045A CAMPBELL AVE |
| Manufacturer City | MENLO PARK CA 94025 |
| Manufacturer Country | US |
| Manufacturer Postal | 94025 |
| Manufacturer Phone | 6507394427 |
| Manufacturer G1 | EARLENS CORPORATION |
| Manufacturer Street | 4045A CAMPBELL AVE |
| Manufacturer City | MENLO PARK CA 94025 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94025 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EARLENS IMPRESSION KIT |
| Generic Name | IMPRESSION KIT |
| Product Code | LDG |
| Date Received | 2016-11-07 |
| Device Expiration Date | 2017-03-31 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EARLENS CORPORATION |
| Manufacturer Address | 4045A CAMPBELL AVE MENLO PARK CA 94025 US 94025 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-11-07 |