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

Model Number	SPAT030US
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	08/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had an allergic reaction to metal hinges, specifically burning sensation that took 6 hours to go away.

• Brand Name: RESPIRE PINK AT
• Common Device Name: DEVICE, ANTI-SNORING
• Manufacturer (Section D): RESPIRE MEDICAL; 63 flushing ave unit 303; suite 601; brooklyn NY 11205
• Manufacturer (Section G): MODERN DENTAL LABORATORY (DG) CO., LTD.; no. 7. nantou road; room 102 & 1102 & floor 4-10; dongguan, guangdong 52300 0; CH 523000
• Manufacturer Contact: david walton ; 63 flushing ave; building 303, suite 601; brooklyn, NY 11205 ; 7186437326
• MDR Report Key: 16242613
• Report Number: 3008937561-2022-00029
• Device Sequence Number: 15066355
• Product Code: LRK
• UDI-Device Identifier: 00851861007253
• UDI-Public: (01)00851861007253(20)113043
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K192127
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 01/25/2023

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 Model Number: SPAT030US
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2022
• Initial Report FDA Received Date: 01/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male