MAUDE Adverse Event Report: RESPIRE MEDICAL RESPIRE PINK SERIES - HERBST; DEVICE, ANTI-SNORING

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	08/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient had an allergic reaction to the oral appliance.Respire medical notifies its customers about potential allergic reactions in its patient labeling.
Event or Problem Description
A respire medical customer service representative received a call from a customer stating that they had experienced an allergic reaction to our device.

• Brand Name: RESPIRE PINK SERIES - HERBST
• Common Device Name: DEVICE, ANTI-SNORING
• Manufacturer (Section D): RESPIRE MEDICAL; 18 bridge street; suite 3i; brooklyn NJ 11201
• MDR Report Key: 7878630
• Report Number: 3008937561-2018-00009
• Device Sequence Number: 13509965
• Product Code: LRK
• UDI-Device Identifier: 00851861007079
• UDI-Public: 00851861007079
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K131138
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 09/14/2018

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/01/2018
• Initial Report FDA Received Date: 09/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1