MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-08-24 for BLOM-SINGER BE 2014 manufactured by Freudenberg Medical, Llc.
[83516318]
This report was originally submitted on 3/31/2017, in an incorrect format. This was initially discovered on 8/23/2017, and this is being re-submitted on 8/24/2017.
Patient Sequence No: 1, Text Type: N, H10
[83516319]
Patient posted on an internet blog on (b)(6) 2017; they had a voice prosthesis that was aspirated. A physician was able to remove the voice prosthesis from the patient's lungs.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2025182-2017-00001 |
| MDR Report Key | 6817262 |
| Report Source | CONSUMER |
| Date Received | 2017-08-24 |
| Date of Report | 2017-03-31 |
| Date of Event | 2017-03-15 |
| Date Added to Maude | 2017-08-24 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. ALYSE MENCIAS |
| Manufacturer City | CARPINTERIA CA 93013 |
| Manufacturer Country | US |
| Manufacturer Postal | 93013 |
| 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 PROTHESIS |
| Product Code | EWL |
| Date Received | 2017-08-24 |
| Catalog Number | BE 2014 |
| Lot Number | 0000045318 |
| Device Expiration Date | 2019-10-12 |
| 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 93013 US 93013 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2017-08-24 |