MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-05-03 for EARGO N/A 99-0023-001 manufactured by Eargo, Inc..
[74329460]
The flexi fibers were not returned; therefore a physical product analysis was not possible. However, the following reviews were conducted: - all possible lot history records for the devices. No nonconforming material reports were initiated for these lots. - design testing, validation and risk management files. Flexi fibers are made of a biocompatible silicone material. - user guide includes the following, "flexi fibers are secured nice and tight. Please do not try to remove them or this will damage the eargo. " - customer complaints from the last 2 years. There were no other such reports of flexi fibers being left in a patient's ear(s) without the patient realizing it. Eargo's chief clinical and science officer spoke with the patient. The patient does not remember intentionally removing the flexi fibers while cleaning his devices, but they may have been loose prior to placement in the ear. The patient has been reminded that a device with a loosely attached flexi fiber should not be used. Additionally, in the event a flexi fiber detaches and could not be located upon device removal, the patient has been advised to have a healthcare professional verify it did not remain in the ear.
Patient Sequence No: 1, Text Type: N, H10
[74329461]
A patient reported to eargo on april 6, 2017 that during a doctor's visit in (b)(6) 2016 (for an unrelated matter), a flexi fiber was discovered in each of his ear canals and removed with a long probe. The patient was surprised by the discovery, as he remembered removing different eargo devices at various times and the flexi fibers were missing. He thought the flexi fibers had come off outside the ear. In (b)(6) 2017, the patient got the flu which turned into a sinus infection after about a week. In mid-(b)(6), the patient was seen by his physician who prescribed an antibiotic (augmentin). He got better for a few days, then worse. Over the next month, the physician prescribed other antibiotics (z-pack and levofloxacin) and a steroid (prednisone) to treat the fluid buildup in his right ear. Each time the patient got better for a while, then worse. The patient's right ear still had fluid buildup, and was referred to an ent practice. On (b)(6) 2017, an ent physician assistant examined the patient's right ear. She discovered and removed a flexi fiber from the ear canal. Crusting and moist debris found beneath was debrided, and the tympanic membrane was intact and clear. A depression in the mid portion of the inferior canal was crusted over. The patient was given ciprodex drops for the infection and asked to return for further cleaning. The flexi fiber was found below the original flexi fiber the physician removed in (b)(6) 2016. The patient believes the flexi fiber had been lodged in his ear canal for over a year. He remembered removing his eargo device and the flexi fiber was missing. He was unable to locate it and thought it had come off, possibly due to removing it too quickly. On (b)(6) 2017, the patient returned for his follow-up visit for his right ear. The ent physician assistant removed the canal crust and exposed bone in the lateral to medial two-third of the inferior canal was observed. The patient was instructed to keep the ear covered when showering. On (b)(6) 2017, the patient returned for a follow-up visit. He has done well since his last visit. He has no pain, drainage or fever and there is no change in his hearing. Epithelium was observed over proximately two-thirds of what was previously exposed bone. The remaining bony projection now lies above the epithelium as it is healing underneath. Burow's solution was recommended to help dry out his ear and the patient was instructed to keep his ear dry.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010841212-2017-00001 |
| MDR Report Key | 6541693 |
| Report Source | CONSUMER |
| Date Received | 2017-05-03 |
| Date of Report | 2017-04-06 |
| Date of Event | 2017-03-31 |
| Date Mfgr Received | 2017-04-06 |
| Date Added to Maude | 2017-05-03 |
| 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. CARMEN LAM |
| Manufacturer Street | 295 N. BERNARDO AVENUE SUITE 100 |
| Manufacturer City | MOUNTAIN VIEW CA 94043 |
| Manufacturer Country | US |
| Manufacturer Postal | 94043 |
| Manufacturer Phone | 4152978612 |
| Manufacturer G1 | EARGO, INC. |
| Manufacturer Street | 295 N. BERNARDO AVENUE SUITE 100 |
| Manufacturer City | MOUNTAIN VIEW CA 94043 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94043 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EARGO |
| Generic Name | HEARING AID, AIR CONDUCTION |
| Product Code | ESD |
| Date Received | 2017-05-03 |
| Model Number | N/A |
| Catalog Number | 99-0023-001 |
| Lot Number | UNKNOWN |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EARGO, INC. |
| Manufacturer Address | 295 N. BERNARDO AVENUE SUITE 100 MOUNTAIN VIEW CA 94043 US 94043 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-05-03 |