MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-26 for BLOM-SINGER BE 2018 manufactured by Freudenberg Medical, Llc.
| Report Number | 2025182-2020-00001 |
| MDR Report Key | 9760174 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-02-26 |
| Date of Report | 2020-02-25 |
| Date of Event | 2020-01-30 |
| Date Mfgr Received | 2020-01-30 |
| Date Added to Maude | 2020-02-26 |
| 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 | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. MATTHEW ARBOGAST |
| Manufacturer Street | 1110 MARK AVE |
| Manufacturer City | CARPINTERIA, CA |
| Manufacturer Country | US |
| Manufacturer Phone | 5765471 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BLOM-SINGER |
| Generic Name | VOICE PROSTHESIS |
| Product Code | EWL |
| Date Received | 2020-02-26 |
| Catalog Number | BE 2018 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FREUDENBERG MEDICAL, LLC |
| Manufacturer Address | 1110 MARK AVE CARPINTERIA, CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2020-02-26 |