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

Model Number	IN 1608-NS
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Pneumonia (2011)
Date of Event	05/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
While the reported complaint was received on 06/06/2019, it was not until 11/05/2019 that information was received that alleged the pneumonia was attributable to the complaint device.While the reported diagnosis of aspiration pneumonia is verified, the reported complaint of leakage was not.Since the devices were not returned, they could not undergo leak tests.However, it is a recognized risk that aspiration pneumonia may result from leakage of fluid through a voice prosthesis.
Event or Problem Description
The voice prosthesis was inserted on (b)(6) 2019 and was reported to be leaking on (b)(6) 2019.The device was inspected by a physicians assistant who determined it was fine and did not remove it.The patient visited the er on (b)(6) 2019 and was admitted to the hospital the same day.The patient was diagnosed with aspiration pneumonia.Although it was initially reported that the patient had been diagnosed with pneumonia, it was not until (b)(6) 2019 that information was received which alleged the device contributed to the pneumonia specifically the physician's assistant reported that the patient had his tep changed several times during the month of may.The patient was treated with broad-spectrum antibiotics (zosyn and vancomycin).The devices were discarded and are not available for evaluation.

• Brand Name: BLOM-SINGER
• Common Device Name: VOICE PROSTHESIS
• Manufacturer (Section D): FREUDENBERG MEDICAL, LLC; 1110 mark ave; carpinteria CA 93013
• MDR Report Key: 9419237
• Report Number: 2025182-2019-00002
• Device Sequence Number: 19250439
• Product Code: EWL
• UDI-Device Identifier: 00813307011088
• UDI-Public: (01)00813307011088(17)220426(10)0000123712
• Combination Product (Y/N): N
• PMA/510(K) Number: K932120
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/05/2019

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: Health Professional
• Device Expiration Date: 04/26/2022
• Device Model Number: IN 1608-NS
• Device Catalogue Number: IN 1608-NS
• Device Lot Number: 0000123712
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/06/2019
• Initial Report FDA Received Date: 12/05/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization