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

Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	10/31/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This product was a part of an fda (b)(4) and has been subsequently recalled with the knowledge of fda.Capa (b)(4) was opened prior to the incident.Further investigation is being conducted.
Event or Problem Description
A respire medical customer service representative spoke with (b)(6), a doctor's staff member and was told that the patient woke up with a broken hinge in his mouth.There was no injury to the patient.

• Brand Name: RESPIRE PINK SERIES - HERBST
• Common Device Name: DEVICE, ANTI SNORING
• Manufacturer (Section D): RESPIRE MEDICAL; 18 bridge street, suite 4j; brooklyn NY 11201
• MDR Report Key: 7595377
• Report Number: 3008937561-2018-00001
• Device Sequence Number: 13497394
• Product Code: LRK
• UDI-Device Identifier: 00851861007079
• UDI-Public: 00851861007079
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 06/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/31/2017
• Initial Report FDA Received Date: 06/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1