MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-08-23 for BLOM-SINGER manufactured by Freudenberg Medical, Llc.
[83456089]
A contractor discovered a website showing an x-ray of an aspirated voice prosthesis. Based on the dimensions of the radiopaque ring, the contractor indicated that the device was a classic indwelling voice prosthesis. The website did not specifically indicate that the prosthesis was a device manufactured by freudenberg medical. No additional details concerning this adverse event could be found on the website. The author of the website, a physician, was contacted to obtain more information; however, no additional information was available since the x-ray image did not have patient identifiers.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2025182-2017-00004 |
| MDR Report Key | 6815794 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-08-23 |
| Date of Report | 2017-08-23 |
| Date Mfgr Received | 2017-08-04 |
| Date Added to Maude | 2017-08-23 |
| 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 | JONATHAN LEE |
| Manufacturer Street | 1110 MARK AVENUE |
| Manufacturer City | CARPINTERIA CA 93013 |
| Manufacturer Country | US |
| Manufacturer Postal | 93013 |
| 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 | 2017-08-23 |
| Operator | HEALTH PROFESSIONAL |
| 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. Required No Informationntervention | 2017-08-23 |