MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 1999-10-04 for ACCUFIT A28201 manufactured by Beltone Electronics Corp..
[135294]
The hearing aid (h/a) dispenser took an impression on 08/14/1999 of the pt's ear for a remake of an aid that had become damaged. Later his dr found that there was some of the impression material in the pt's ear. The ear had become infected. The pt is waiting for the infection to clear before removing the material surgically from the ear.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1416900-1999-00038 |
| MDR Report Key | 243588 |
| Report Source | 00 |
| Date Received | 1999-10-04 |
| Date of Report | 1999-08-25 |
| Date of Event | 1999-08-01 |
| Date Mfgr Received | 1999-08-25 |
| Date Added to Maude | 1999-10-12 |
| 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 |
| Reporter Occupation | AUDIOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | DEAN HAYES |
| Manufacturer Street | 4201 W VICTORIA ST |
| Manufacturer City | CHICAGO IL 60646 |
| Manufacturer Country | US |
| Manufacturer Postal | 60646 |
| Manufacturer Phone | 7735833600 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| 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 | 1999-10-04 |
| Model Number | NA |
| Catalog Number | A28201 |
| Lot Number | NA |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 235977 |
| Manufacturer | BELTONE ELECTRONICS CORP. |
| Manufacturer Address | 4201 W. VICTORIA ST. CHICAGO IL 60646 US |
| Baseline Brand Name | ACCUFIT |
| Baseline Generic Name | IMPRESSION MATERIAL |
| Baseline Model No | NA |
| Baseline Catalog No | A28201 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1999-10-04 |