MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-04-30 for HERBST manufactured by Allesee Orthodontic Appliances.
[21657105]
A doctor's office alleged that a patient had swallowed the right mini-scope herbst mechanism.
Patient Sequence No: 1, Text Type: D, B5
[21882982]
The patient sought medical attention from a family physician and was prescribed a laxative for treatment; however, the part did not pass. On (b)(6) 2013, the patient went to the emergency room and received further treatment; however, the doctor's office was not definitive as to whether the treatment received was a laxative or an enema. It was reported that the part had passed and was observed by the hospital staff during the er visit. The doctor's office reported that they followed up with the patient on (b)(6) 2013 and it was confirmed that the patient is doing well and has fully recovered. The device was not returned; therefore, no evaluation can be conducted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2184045-2013-00006 |
| MDR Report Key | 3086418 |
| Report Source | 05 |
| Date Received | 2013-04-30 |
| Date of Report | 2013-04-03 |
| Date Mfgr Received | 2013-04-03 |
| Date Added to Maude | 2013-05-01 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MRS. KERRI CASINO |
| Manufacturer Street | 1717 W COLLINS AVE |
| Manufacturer City | ORANGE CA 92867 |
| Manufacturer Country | US |
| Manufacturer Postal | 92867 |
| Manufacturer Phone | 7145167634 |
| Manufacturer G1 | ALLESEE ORTHODONTIC APPLIANCES |
| Manufacturer Street | 13931 SPRING STREET |
| Manufacturer City | STURTEVANT WI 53177 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53177 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HERBST |
| Generic Name | BITE-JUMPING ORTHODONTIC APPLIANCE |
| Product Code | EJF |
| Date Received | 2013-04-30 |
| ID Number | WO #7500316 |
| Operator | OTHER |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALLESEE ORTHODONTIC APPLIANCES |
| Manufacturer Address | 13931 SPRING STREET STURTEVANT WI 53177 US 53177 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2013-04-30 |