MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-05 for 05-001 manufactured by .
[119327217]
Without return of the product in question it is not possible to confirm or deny customer complaint, but the product as reviewed supports the intended function. Review of current inventory demonstrates the injection molded tooth protector satisfies the drawing requirements for wall thickness and sunmed requirements. This product is sold as non-sterile but this customer utilizes eto sterilization on the product which could negatively impact strength or flexibility of the tooth guard. Testing for eto compatibility should be conducted by the customer as this is outside of sunmed's control since the tooth protector is sold as a non-sterile product. Additionally, the material is a thermoplastic elastomer (tpe) which has a natural flexibility or rubber like feel. Biting or puncturing this material will cause it to split but not fragment into pieces therefore the concern of pieces breaking free is not inherent to the natural state of the material as sold by sunmed.
Patient Sequence No: 1, Text Type: N, H10
[119327218]
The customer alleges that " when mouthguard was removed at the end of procedure it was found to have a hole in it. " no other details were provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1314417-2018-00024 |
| MDR Report Key | 7847706 |
| Date Received | 2018-09-05 |
| Date of Report | 2018-08-09 |
| Date Added to Maude | 2018-09-05 |
| 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 | 0 |
| Generic Name | DENTAL PROTECTOR |
| Product Code | BRW |
| Date Received | 2018-09-05 |
| Model Number | 05-001 |
| Lot Number | 400447 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-09-05 |