MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2016-04-14 for BLOM-SINGER ADVANTAGE AD2010-NS manufactured by Freudenberg Medical, Llc.
[42744116]
The patient reported that voice prosthesis leaked. They stated they were in the hospital for aspiration pneumonia possibly due to the leakage.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2025182-2016-00002 |
| MDR Report Key | 5579976 |
| Report Source | CONSUMER |
| Date Received | 2016-04-14 |
| Date of Report | 2016-04-14 |
| Date of Event | 2016-01-15 |
| Date Mfgr Received | 2016-03-22 |
| Date Added to Maude | 2016-04-14 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. ALYSE MENCIAS |
| Manufacturer Street | 1110 MARK AVENUE |
| Manufacturer City | CARPINTERIA 93013 |
| Manufacturer Country | US |
| Manufacturer Postal | 93013 |
| Manufacturer Phone | 8055765482 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BLOM-SINGER ADVANTAGE |
| Generic Name | VOICE PROSTHESIS |
| Product Code | EWL |
| Date Received | 2016-04-14 |
| Model Number | AD2010-NS |
| Catalog Number | AD2010-NS |
| 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 AVENUE CARPINTERIA CA 93013 US 93013 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2016-04-14 |