MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-05-01 for RESPIRE PINK SERIES WITH DENTITRAC SP000US manufactured by Respire Medical Holding.
[143750277]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008937561-2019-00010 |
| MDR Report Key | 8571028 |
| Report Source | USER FACILITY |
| Date Received | 2019-05-01 |
| Date of Report | 2019-05-03 |
| Date of Event | 2019-02-22 |
| Date Mfgr Received | 2019-04-24 |
| Device Manufacturer Date | 2019-01-22 |
| Date Added to Maude | 2019-05-01 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. MADUBUIKE OKAFOR |
| Manufacturer Street | 18 BRIDGE ST. SUITE 3J |
| Manufacturer City | BROOKLYN NY 11201 |
| Manufacturer Country | US |
| Manufacturer Postal | 11201 |
| Manufacturer Phone | 7183609209 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RESPIRE PINK SERIES WITH DENTITRAC |
| Generic Name | DEVICE, ANTI-SNORING |
| Product Code | LRK |
| Date Received | 2019-05-01 |
| Returned To Mfg | 2019-04-30 |
| Model Number | SP000US |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RESPIRE MEDICAL HOLDING |
| Manufacturer Address | 18 BRIDGE STREET SUITE 3J BROOKLYN NY 11201 US 11201 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-05-01 |