MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2016-06-13 for UNITEK(TM) MIA MOBILE INTRAORAL ARCH 340-006 manufactured by 3m Unitek Corporation.
[47213942]
Patient was eating dinner, his orthodontic palate expander broke and a 4cm section of the device and was swallowed. The patient had x-rays and gastroscopy which determined the wire piece was in the small intestine. It was removed via endoscopy. The doctor prescribed a ppi, omeprazole, for 2 weeks.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020467-2016-00003 |
| MDR Report Key | 5719969 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-06-13 |
| Date of Report | 2016-06-01 |
| Date of Event | 2016-05-23 |
| Date Mfgr Received | 2014-06-09 |
| Date Added to Maude | 2016-06-13 |
| 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 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KATHLEEN BACON |
| Manufacturer Street | 2724 SOUTH PECK ROAD |
| Manufacturer City | MONROVIA CA 910165097 |
| Manufacturer Country | US |
| Manufacturer Postal | 910165097 |
| Manufacturer Phone | 6265744212 |
| Manufacturer G1 | 3M UNITEK CORPORATION |
| Manufacturer Street | 2724 SOUTH PECK ROAD |
| Manufacturer City | MONROVIA CA 910165097 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 910165097 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNITEK(TM) MIA MOBILE INTRAORAL ARCH |
| Generic Name | INTRAORAL ORTHODONTIC PALATAL APPLIANCE |
| Product Code | DYJ |
| Date Received | 2016-06-13 |
| Catalog Number | 340-006 |
| Lot Number | UNKNOWN |
| Operator | DENTIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M UNITEK CORPORATION |
| Manufacturer Address | 2724 SOUTH PECK ROAD MONROVIA CA 910165097 US 910165097 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-06-13 |