MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-15 for EARGO N/A 99-0009-001 manufactured by Eargo, Inc..
[36213263]
Eargo has requested that the patient obtain a hearing test post sample removal. Because test results are not yet available, the reported event cannot be confirmed. While eargo's complaint investigation is ongoing, this event is being filed as an mdr in an abundance of caution to ensure full compliance with 21 cfr part 803. Eargo will supplement this mdr if/when additional information becomes available. The sizing sample intended to be non-functional has not been returned; therefore, product failure analysis was not possible. The specific lot number could not be distinguished from multiple lots shipped to customers that day. However, a review of all possible lot history records for the sample was performed and no nonconforming material reports were initiated for these lots. The sample provided is intended for sizing purposes and single use only. The brochure containing the samples and the label placed on each sample were reviewed. The brochure refers to the eargos as "samples" and provide instructions on how to obtain "real eargo devices. " the label on each sample states "non-working sample, single use only, and read usage instructions. "
Patient Sequence No: 1, Text Type: N, H10
[36213266]
Following the use of the company's sizing sample intended to be non-functional, the patient alleges her hearing is reduced and now experiences pain, ringing in her ears, and severe discomfort. When the patient received her sizing samples (sizes 12 and 15), she observed that the size 15 sample was missing a removal thread. Patient also indicates that the size 15 sample was big and did not fit inside her ear. Patient states that even though there was no thread on the size 15 sample, she did not anticipate having a problem removing it as it was too big. Patient also indicates that she was initially able to remove it easily from her ear. On the third day of use, patient states that she was unable to remove the sample from her ear. Her physician referred her to an ent specialist who was able to remove it.
Patient Sequence No: 1, Text Type: D, B5
[39778300]
Eargo has received the patient's audiograms that were performed pre- and post- reported event and reviewed by the company's medical (ent). The pre-event audiogram was performed at (b)(6) on (b)(6) 2015 and the post-event audiogram was performed on (b)(6) 2016 at (b)(6). Both audiograms report a mild to moderate hearing loss. Minor differences found between the audiograms, 5db - 20db, are well within the test/retest variability of pure tone audiograms, especially with different examiners. Both audiograms show very good word discrimination results. Based on the audiograms reviewed, there is no evidence that there was hearing damage caused by the reported event. Information from initial report: the sizing sample intended to be non-functional has not been returned; therefore, product failure analysis was not possible. The specific lot number could not be distinguished from multiple lots shipped to customers that day. However, a review of all possible lot history records for the sample was performed and no nonconforming material reports were initiated for these lots. The sample provided is intended for sizing purposes and single use only. The brochure containing the samples and the label placed on each sample were reviewed. The brochure refers to the eargos as "samples" and provide instructions on how to obtain "real eargo devices. " the label on each sample states "non-working sample, single use only, and read usage instructions. "
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3010841212-2016-00001 |
| MDR Report Key | 5371893 |
| Date Received | 2016-01-15 |
| Date of Report | 2015-12-18 |
| Date of Event | 2015-11-20 |
| Date Mfgr Received | 2016-02-08 |
| Date Added to Maude | 2016-01-15 |
| 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 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. BIJESH CHANDRAN |
| Manufacturer Street | 295 N. BERNARDO AVENUE SUITE 100 |
| Manufacturer City | MOUNTAIN VIEW CA 94043 |
| Manufacturer Country | US |
| Manufacturer Postal | 94043 |
| Manufacturer Phone | 4087056687 |
| 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 | 2016-01-15 |
| Model Number | N/A |
| Catalog Number | 99-0009-001 |
| Lot Number | UNKNOWN |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| 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. Other | 2016-01-15 |