MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 1999-10-06 for ACCUFIT A282 manufactured by Beltone Electronics Corp..
[183994]
The hearing aid (h/a) specialist took impressions of both ears. The h/a specialist noted a piece of skin 1/4" past the second bend. The pt experienced some bleeding in the ear. The pt stated she was taking a blood thinner prescribed by her doctor. The pt was referred to her doctor and the er. Subsequently the bleeding was controlled. No further injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1416900-1999-00039 |
| MDR Report Key | 243797 |
| Report Source | 00 |
| Date Received | 1999-10-06 |
| Date of Report | 1999-08-30 |
| Date of Event | 1999-08-01 |
| Date Mfgr Received | 1999-08-30 |
| Device Manufacturer Date | 1999-05-01 |
| Date Added to Maude | 1999-10-13 |
| 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 | 0 |
| 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 | 1999-10-06 |
| Model Number | NA |
| Catalog Number | A282 |
| 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 | 236179 |
| 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 | 1999-10-06 |