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.
[83516287]
This report was originally submitted on 1/27/2017, 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
[83516288]
Patient posted on an internet blog on (b)(6) 2016; they had a voice prosthesis that had a "flap" that "curled" causing fluids to be aspirated. The fluid aspirating then lead to pneumonia. Follow up was conducted with the patient and it was confirmed they received treatment for pneumonia following fluid aspiration.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2025182-2016-00009 |
| MDR Report Key | 6817253 |
| Report Source | CONSUMER |
| Date Received | 2017-08-24 |
| Date of Report | 2017-01-27 |
| 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 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 | 2017-08-24 |
| Catalog Number | BE 2014 |
| 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. Required No Informationntervention | 2017-08-24 |