MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-14 for HERBST APPLIANCE WIRONIT manufactured by Bego U.s.a..
[102586559]
Reporter called, on behalf of her son, to report adverse event involving an herbst appliance. The reporter stated that her (b)(6) son was wearing the device in his mouth when a small piece broke off. The reporter said her son swallowed the broken piece and it was seen on x-ray in his intestines. Reporter said the piece was eventually passed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5075874 |
| MDR Report Key | 7340873 |
| Date Received | 2018-03-14 |
| Date of Report | 2018-03-14 |
| Date of Event | 2017-03-01 |
| Date Added to Maude | 2018-03-15 |
| 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 | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HERBST APPLIANCE WIRONIT |
| Generic Name | HERBST APPLIANCE WIRONIT |
| Product Code | EJH |
| Date Received | 2018-03-14 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BEGO U.S.A. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-14 |