MAUDE Adverse Event Report: RESPIRE MEDICAL HOLDING RESPIRE PINK SERIES WITH DENTITRAC; DEVICE, ANTI-SNORING

Model Number	SP000US
Medical Device Problem Codes	Corroded (1131); Crack (1135); Fracture (1260)
Health Effect - Clinical Codes	Burn(s) (1757); Ulceration (2116)
Date of Event	02/22/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
On 4/24/2019 respire medical received a repair for case (b)(4).The dentist's office stated that the patient has a burn on left cheek, and that they believe that the chip leaked and mixed with saliva.The patient reported this to the dentist office on (b)(6) 2019.
Event or Problem Description
On 4/24/2019 respire medical received a repair for case (b)(4).The dentist's office stated that the patient has a burn on left cheek, and that they believe that the chip leaked and mixed with saliva.The patient reported this to the dentist office on (b)(6) 2019.
Additional Manufacturer Narrative
This follow-up report is being filed because a 5 day report was previously filed in error.The burns were not reported as 3rd degree burns.Also, we were not able to confirm that it was a burn mark, so we also included the code for "ulceration".

• Brand Name: RESPIRE PINK SERIES WITH DENTITRAC
• Common Device Name: DEVICE, ANTI-SNORING
• Manufacturer (Section D): RESPIRE MEDICAL HOLDING; 18 bridge street; suite 3j; brooklyn NY 11201
• MDR Report Key: 8571028
• Report Number: 3008937561-2019-00010
• Device Sequence Number: 1537245
• Product Code: LRK
• UDI-Device Identifier: 00851861007086
• UDI-Public: (01)00851861007086
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K170692
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2019

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: SP000US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2019
• Initial Date Received by Manufacturer: 04/24/2019
• Supplement Date Received by Manufacturer: 04/24/2019
• Initial Report FDA Received Date: 05/01/2019
• Supplement Report FDA Received Date: 05/03/2019
• 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: Other
• Patient Age: 41 YR
• Patient Weight: 181