MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 1998-04-24 for ACCUFIT A282 manufactured by Beltone Electronics Corp..
[95953]
The hearing aid (h/a) user came into the dispenser's office with a broken hearing aid. The dispenser made an impression of her ear. When the impression was removed, the client complained that she couldn't hear as well as when she came in the office. Client saw a doctor who diagnosed a perforated left ear. The doctor patched the perforation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1416900-1998-00021 |
| MDR Report Key | 164284 |
| Report Source | 00 |
| Date Received | 1998-04-24 |
| Date of Report | 1998-03-13 |
| Date of Event | 1998-03-01 |
| Date Mfgr Received | 1998-03-18 |
| Device Manufacturer Date | 1994-10-01 |
| Date Added to Maude | 1998-04-28 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACCUFIT |
| Generic Name | IMPRESSION MATERIAL |
| Product Code | LDG |
| Date Received | 1998-04-24 |
| Model Number | NA |
| Catalog Number | A282 |
| Lot Number | NA |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 159909 |
| Manufacturer | BELTONE ELECTRONICS CORP. |
| Manufacturer Address | 4201 WEST VICTORIA ST. CHICAGO IL 60646 US |
| Baseline Brand Name | ACCUFIT |
| Baseline Generic Name | IMPRESSION MATERIAL |
| Baseline Model No | NA |
| Baseline Catalog No | A282 |
| Baseline ID | NA |
| Baseline Device Family | KIT, EARMOLD IMPRESSION |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 12 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K963958 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1998-04-24 |