MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-03-31 for * manufactured by Medel Development.
[819872]
Mother of a child called to report that after 10 days using the device, her child chewed it, and it is unknown if the fragmented piece was swallowed or not. She stated that her child needs to wear this device 24 hr/day for 3-4 weeks to get the results which is to help her stop sucking.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5006049 |
| MDR Report Key | 1021514 |
| Date Received | 2008-03-31 |
| Date of Report | 2008-03-31 |
| Date Added to Maude | 2008-04-08 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | FINGER SUCKING DEVICE |
| Product Code | LQX |
| Date Received | 2008-03-31 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | OTHER |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 991066 |
| Manufacturer | MEDEL DEVELOPMENT |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-03-31 |