MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-04-23 for SNORE GUARD manufactured by Ranir Llc.
[142784230]
Sample was returned. Customer complaint of "blue part broken" was confirmed. Snoreguard device is fitted by the user. Instructions are provided for the fitting process which describe the process in detail. If directions are not followed, either the biting force into the lower bite pad extender ramp can be too early, can be excessive, and/or the heating time can be too long resulting in excessive softening of the bite pad extender ramp. Information in regards to the storage conditions and external environmental factors (heat, light, moisture) in which the device was subjected to was not provided but may have played a role in this specific customer? S experience. Complaint data reveals failure mode is isolated in nature.
Patient Sequence No: 1, Text Type: N, H10
[142784231]
Consumer stated the blue part broke.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1825660-2019-00544 |
| MDR Report Key | 8539378 |
| Report Source | CONSUMER |
| Date Received | 2019-04-23 |
| Date of Report | 2019-04-23 |
| Date of Event | 2019-04-08 |
| Date Facility Aware | 2019-04-08 |
| Date Mfgr Received | 2019-04-08 |
| Date Added to Maude | 2019-04-23 |
| 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 | REBEKAH STENSKE |
| Manufacturer Street | 4701 EAST PARIS AVE. SE |
| Manufacturer City | GRAND RAPIDS MI 495125353 |
| Manufacturer Country | US |
| Manufacturer Postal | 495125353 |
| Manufacturer Phone | 6166988880 |
| Manufacturer G1 | RANIR LLC |
| Manufacturer Street | 4701 EAST PARIS AVE. SE |
| Manufacturer City | GRAND RAPIDS MI 495125353 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 495125353 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SNORE GUARD |
| Generic Name | DEVICE, ANTI-SNORING |
| Product Code | LRK |
| Date Received | 2019-04-23 |
| Returned To Mfg | 2019-04-08 |
| Model Number | SNORE GUARD |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RANIR LLC |
| Manufacturer Address | 4701 EAST PARIS AVE. SE GRAND RAPIDS MI 495125353 US 495125353 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-23 |