MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2016-10-07 for BLOM-SINGER manufactured by Freudenberg Medical, Llc.
[56809511]
Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[56809512]
While performing a literature review on september 16, 2016, a journal article was discovered regarding an aspirated classic 10 mm indwelling voice prosthesis. The article stated a patient was cleaning the device when it came out, the patient tried to replace the device and was unsuccessful. The patient was admitted into the department of otolaryngology head and neck surgery at (b)(6) hospital in (b)(6) 2011. The admission was for suspected aspiration of the prosthesis. The device was discovered in the lungs using chest radiography. The device was subsequently removed using flexible bronchoscope.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2025182-2016-00005 |
| MDR Report Key | 6011511 |
| Report Source | LITERATURE |
| Date Received | 2016-10-07 |
| Date of Report | 2016-10-07 |
| Date of Event | 2011-07-15 |
| Date Added to Maude | 2016-10-07 |
| 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 AVE |
| Manufacturer City | CARPINTERIA CA 93013 |
| Manufacturer Country | US |
| Manufacturer Postal | 93013 |
| Manufacturer Phone | 8055765414 |
| Manufacturer G1 | FREUDENBERG MEDICAL, LLC |
| Manufacturer Street | 1110 MARK AVE |
| Manufacturer City | CARPINTERIA CA 93013 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 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 | 2016-10-07 |
| Device Availability | * |
| 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 93013 US 93013 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-10-07 |