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

Model Number SP020US

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Inflammation (1932)

Event Date 06/05/2020

Event Type  Injury  

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 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)
• Type of Device: DEVICE, ANTI-SNORING, PRODUCT CODE: LRK
• Manufacturer (Section D): RESPIRE MEDICAL; 18 bridge st.; suite 3j; brooklyn, NY 11201
• Manufacturer (Section G): RESPIRE MEDICAL; 18 bridge st.; suite 3j; brooklyn NY 11201
• Manufacturer Contact: madubuike okafor ; 18 bridge st.; suite 3j; brooklyn, NY 11201 ; 7183609209
• MDR Report Key: 10853910
• MDR Text Key: 216673820
• Report Number: 3008937561-2020-02012
• Device Sequence Number: 1
• Product Code: LRK
• UDI-Device Identifier: 00851861007079
• UDI-Public: (01)00851861007079
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K131138
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: SP020US
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/05/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/06/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization