MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2014-11-17 for BLOM-SINGER VOICE PROSTHESIS IN2014-NS manufactured by Helix Medical, Llc.
[5294394]
The pt reported that while they were inserting their voice prosthesis they inhaled and swallowed the prosthesis. After a consult with x-rays performed, the pt was then scheduled for a bronchoscopy to verify if the prosthesis has dropped into the lungs.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2025182-2014-00003 |
| MDR Report Key | 4273005 |
| Report Source | 04 |
| Date Received | 2014-11-17 |
| Date of Report | 2014-11-11 |
| Date of Event | 2014-11-11 |
| Date Mfgr Received | 2014-11-11 |
| Date Added to Maude | 2014-11-25 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | BELINDA JACKSON |
| Manufacturer Street | 1110 MARK AVE. |
| Manufacturer City | CARPINTERIA CA 93013 |
| Manufacturer Country | US |
| Manufacturer Postal | 93013 |
| Manufacturer Phone | 8055765308 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BLOM-SINGER VOICE PROSTHESIS |
| Generic Name | VOICE PROSTHESIS |
| Product Code | EWL |
| Date Received | 2014-11-17 |
| Model Number | IN2014-NS |
| Catalog Number | IN2014-NS |
| Lot Number | 1006372 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HELIX MEDICAL, LLC |
| Manufacturer Address | CARPINTERIA CA 93013 US 93013 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-11-17 |