BLOM-SINGER ADVANTAGE AS1606-NS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-04-14 for BLOM-SINGER ADVANTAGE AS1606-NS manufactured by Freudenberg Medical, Llc.

Event Text Entries

[42743703] The healthcare professional reported that the patient lost their prosthesis and requested a bronchoscopy be performed.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2025182-2016-00003
• MDR Report Key: 5579659
• Report Source: HEALTH PROFESSIONAL
• Date Received: 2016-04-14
• Date of Report: 2016-04-14
• Date of Event: 2016-03-24
• Date Mfgr Received: 2016-03-24
• Device Manufacturer Date: 2016-02-01
• Date Added to Maude: 2016-04-14
• 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
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MRS. ALYSE MENCIAS
• Manufacturer Street: 1110 MARK AVENUE
• Manufacturer City: CARPINTERIA CA 93013
• Manufacturer Country: US
• Manufacturer Postal: 93013
• Manufacturer Phone: 8055765482
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: BLOM-SINGER ADVANTAGE
• Generic Name: VOICE PROSTHESIS
• Product Code: EWL
• Date Received: 2016-04-14
• Model Number: AS1606-NS
• Catalog Number: AS1606-NS
• Lot Number: 0000023077
• Device Expiration Date: 2019-02-28
• 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 AVENUE CARPINTERIA CA 93013 US 93013

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2016-04-14