MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-02-13 for EARMATE-4220 "CRYSTAL" HH-4220 4220R manufactured by Hearing Help Express.
[99957223]
Device was returned to hearing help express (a repackager/relabeler) logged, and forwarded to the original device manufacturer for evaluation. Manufacturer measured dome retention force on returned hearing device and confirmed the retention force complies with specification (iec (b)(6)). Manufacturer also confirmed retention force on new dome and new hearing device complies with specification. Manufacturer compared (visually and microscopically) the returned hearing device/dome to a new hearing device/dome and no differences were observed. The instructions for use were reviewed. When the user changes domes they are instructed to gently tug and twist the dome to ensure it is securely attached. There is a caution statement in bold red italic font indicating "it is important the dome is firmly attached so it does not fall off in your ear".
Patient Sequence No: 1, Text Type: N, H10
[99957224]
A hearing aid dome got stuck in one patient's right ear, unknowingly, for about a week. After growing discomfort she went to her doctor, who extracted the dome, although not before an infection developed. The dr told her she had a hole in her eardrum but couldn't tell if it was caused by the infection or if it was there before.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002795789-2018-00001 |
| MDR Report Key | 7268029 |
| Report Source | CONSUMER |
| Date Received | 2018-02-13 |
| Date of Report | 2018-01-11 |
| Date of Event | 2018-01-09 |
| Date Mfgr Received | 2018-01-11 |
| Device Manufacturer Date | 2017-06-28 |
| Date Added to Maude | 2018-02-13 |
| 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 | MR. KEVIN LEONARD |
| Manufacturer Street | 1714 SYCAMORE ROAD |
| Manufacturer City | DEKALB IL 60115 |
| Manufacturer Country | US |
| Manufacturer Postal | 60115 |
| Manufacturer Phone | 8157873551 |
| Manufacturer G1 | INTRICON CORPORATION |
| Manufacturer Street | 1260 RED FOX ROAD |
| Manufacturer City | ARDEN HILLS MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55112 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EARMATE-4220 "CRYSTAL" |
| Generic Name | AID-CONDUCTION HEARING AID |
| Product Code | ESD |
| Date Received | 2018-02-13 |
| Returned To Mfg | 2018-01-22 |
| Model Number | HH-4220 |
| Catalog Number | 4220R |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HEARING HELP EXPRESS |
| Manufacturer Address | 1714 SYCAMORE ROAD DEKALB MN 60115 US 60115 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-02-13 |