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 DB16-008 manufactured by Freudenberg Medical, Llc.
[83510168]
Patient Sequence No: 1, Text Type: N, H10
[83510169]
Patient's spouse called in on 10/27/2016 to report the patient's voice prosthesis started leaking. The device was placed on (b)(6) 2016 and removed due to the event on (b)(6) 2016. The patient was seen by their speech language pathologist (slp) who stated the patient had an infection in the trachea. The patient was subsequently admitted to the hospital for pneumonia. Follow up with the slp found that the device was "colonized with fungal growth" which reportedly lead to the leakage and the subsequent infection and pneumonia.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2025182-2016-00007 |
| MDR Report Key | 6817200 |
| Report Source | CONSUMER |
| Date Received | 2017-08-24 |
| Date of Report | 2016-11-18 |
| Date of Event | 2016-09-27 |
| Date Mfgr Received | 2016-10-27 |
| Device Manufacturer Date | 2016-08-17 |
| 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 | DB16-008 |
| Lot Number | 0000040294 |
| Device Expiration Date | 2019-08-31 |
| 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. Hospitalization | 2017-08-24 |