MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-12-29 for EARLENS IMPRESSION KIT manufactured by Earlens Corporation.
[63607726]
Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[63607727]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010863048-2016-00002 |
| MDR Report Key | 6214578 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-12-29 |
| Date of Report | 2016-12-06 |
| Date of Event | 2016-12-02 |
| Date Mfgr Received | 2016-12-06 |
| Date Added to Maude | 2016-12-29 |
| 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 | 2016-12-29 |
| 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 | 2016-12-29 |