MAUDE Adverse Event Report: FREUDENBERG MEDICAL, LLC BLOM-SINGER; VOICE PROSTHESIS

Catalog Number	BE 2014
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Pneumonia (2011)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• Brand Name: BLOM-SINGER
• Common Device Name: VOICE PROSTHESIS
• Manufacturer (Section D): FREUDENBERG MEDICAL, LLC; 1110 mark ave; carpinteria CA 93013
• MDR Report Key: 6817253
• Report Number: 2025182-2016-00009
• Device Sequence Number: 149354
• Product Code: EWL
• UDI-Device Identifier: 00813307010098
• UDI-Public: 00813307010098
• Combination Product (Y/N): N
• PMA/510(K) Number: K930105
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: BE 2014
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention