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

Model Number	SP030US
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Localized Skin Lesion (4542)
Date of Event	11/03/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient experiences reaction from metal to metal in his mouth, possibly galvanic shock.The patient also had significant soft tissue lesions from the screw/hub placement.
Additional Manufacturer Narrative
Lesions are present on both the right and left side of the interior of his lips.They are red and the tissue is uneven and looks like he may be chewing on the tissue in that area.The physician noted that the patient's mouth was very dry.Patient was not tested for allergies to materials but has history of allergic reactions.The patient went to a oral surgeon and was treated for dry mouth and got eloquis to treat lesions.

• Brand Name: RESPIRE PINK EF
• 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: 16242614
• Report Number: 3008937561-2022-00028
• Device Sequence Number: 6454160
• Product Code: LRK
• UDI-Device Identifier: 00851861007062
• UDI-Public: (01)00851861007062
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K150572
• 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: SP030US
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2020
• Initial Report FDA Received Date: 01/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Required Intervention; Other
• Patient Sex: Male