MAUDE Adverse Event Report: RESPIRE MEDICAL RESPIRE PINK (HARD/SOFT); DEVICE, ANTI-SNORING, PRODUCT CODE: LRK

Model Number	SP020US
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	06/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This mdr was originally submitted on 6/12/2020.I waited to see if it would show up on the maude website, however it never did not.When i double checked the acknowledgement, i saw the following error, "must have at least one valid device problem code," and i realized that the original submission actually failed.Because of this, i am resubmitting the mdr.
Event or Problem Description
A respire patient went to the er for inflammation in the gums due to the retention of device being too tight, and the doctor having difficulty removing the device from the patient's mouth.The inflammation eventually went away, and the patient is fine now.This patient's doctor specifies maximum retention as the "preferences" on all his cases.Whenever we make his devices to the standard retention, he states that they are too loose.Moving forward we have to be more conservative on the retention.The medical professional has made chairside adjustments to get it to fit properly, since respire products are custom devices that the medical professional participates in designing.After the chairside adjustments, this doctor determined that the device is suitable for their patient to wear.

• Brand Name: RESPIRE PINK (HARD/SOFT)
• Common Device Name: DEVICE, ANTI-SNORING, PRODUCT CODE: LRK
• Manufacturer (Section D): RESPIRE MEDICAL; 18 bridge st.; suite 3j; brooklyn, NY 11201
• MDR Report Key: 10853910
• Report Number: 3008937561-2020-02012
• Device Sequence Number: 2420143
• Product Code: LRK
• UDI-Device Identifier: 00851861007079
• UDI-Public: (01)00851861007079
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K131138
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/09/2020

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
• Device Model Number: SP020US
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/05/2020
• Initial Report FDA Received Date: 11/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization