MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 1997-06-19 for IMPRESS manufactured by Beltone Electronics Corp..
[55997]
Customer had ear impression taken. Dispenser noted that there was bleeding in the ear when impression was removed. Customer complained of pain in ear. Customer subsequently treated by dr for ear infection. Dr diagnosed a fungal infection. Customer returned for delivery when dr said it was alright. Dispenser noted that ear did not appear ready for aid. Advised to wait one more week. Customer returned in a week and dispenser attempted delivery. Customer complained of pain in the ear. Dispenser noted "raw skin" in ear. Hearing aid was remade from original impression and delivered. Customer is wearing hearing aid with no further problems as of this writing (6/19/97).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1416900-1997-00002 |
| MDR Report Key | 99853 |
| Report Source | 00 |
| Date Received | 1997-06-19 |
| Date of Report | 1997-04-09 |
| Date of Event | 1997-03-01 |
| Date Mfgr Received | 1997-04-09 |
| Date Added to Maude | 1997-06-25 |
| 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 | IMPRESS |
| Generic Name | EAR MOLD IMPRESSION MATERIAL |
| Product Code | LDG |
| Date Received | 1997-06-19 |
| Returned To Mfg | 1997-03-20 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 98376 |
| Manufacturer | BELTONE ELECTRONICS CORP. |
| Manufacturer Address | 4201 WEST VICTORIA ST. CHICAGO IL 60646 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1997-06-19 |