MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-16 for SUNMED manufactured by .
[62611140]
An extensive and thorough investigation was performed by the engineering team that concluded the root cause for this problem is the fact that the patient port and the mask are made out of similar base materials resulting in an undesirably high coefficient of friction between the two parts. Steps have been taken to implement a material combination with a lower coefficient of friction that significantly reduces the effort required to remove the mask from the patient valve.
Patient Sequence No: 1, Text Type: N, H10
[62611141]
The customer alleges "mouth guard was placed on upper teeth while patient was intubated for laryngoscopy procedure. Upon completion of the procedure the mouthguard was removed and it was discovered that the patients two top front teeth were chipped and rough. " no other details were provided.
Patient Sequence No: 1, Text Type: D, B5
[63920053]
The tooth protector was not returned and there is no product with the same lot number in inventory. A sample of (b)(4) pieces of the same part number was visual inspected for flaws or defects in the molding that would expose the teeth. No defects/flaws were found. Based on the available information and the fact that we have never had a similar complaint, there is no reason to believe that the product did not meet a requirement or malfunctioned.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2246980-2016-00075 |
| MDR Report Key | 6181990 |
| Date Received | 2016-12-16 |
| Date of Report | 2016-11-21 |
| Date of Event | 2016-08-05 |
| Date Added to Maude | 2016-12-16 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUNMED |
| Generic Name | TOOTH PROTECTOR |
| Product Code | BRW |
| Date Received | 2016-12-16 |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-12-16 |