MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2001-03-09 for ACCUFIT A282 manufactured by Beltone Electronics Corp..
[16263425]
The hearing aid (h/a) user reported bleeding of the skin of the outer ear after having an earmold impression taken by the hearing aid dispenser. The user sought help from their physician to treat the ear.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1416900-2000-00131 |
| MDR Report Key | 319822 |
| Report Source | 00 |
| Date Received | 2001-03-09 |
| Date of Report | 2000-04-21 |
| Date of Event | 2000-04-01 |
| Date Mfgr Received | 2000-04-21 |
| Date Added to Maude | 2001-03-14 |
| 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 |
| Manufacturer Contact | CLIFF LONG |
| Manufacturer Street | 4201 WEST VICTORIA STREET |
| 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 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACCUFIT |
| Generic Name | IMPRESSION MATERIAL |
| Product Code | LDG |
| Date Received | 2001-03-09 |
| Model Number | NA |
| Catalog Number | A282 |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 309353 |
| Manufacturer | BELTONE ELECTRONICS CORP. |
| Manufacturer Address | 4201 WEST VICTORIA STREET 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 | 2001-03-09 |