MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-07 for HERBST 10040T manufactured by Specialty Appliance Works, Inc.
[49029113]
Each device is manufactured to order according to each patients' anatomy. As such, a device is not to be used by different patients, but rather by a single patient for several months. Please note that a production account for the electronic submissions gateway (esg) was initiated on 6/7/2016. Notification was received on 7/1/2016 that the test submission failed. A new test submission was sent on 7/1/2016. The production account was approved on 7/5/2016. This report was immediately filed on 7/5/2016. Notification was received on 7/7/2016 that the submission failed. A new submission was sent on 7/7/2016.
Patient Sequence No: 1, Text Type: N, H10
[49029114]
On (b)(6) 2016, patient's parent noticed that a wire (. 032" diameter and approximately 21 mm in length) from the expander was missing. The patient was not aware that the wire came off and in advertently swallowed the wire. Patient went to emergency room to seek medical attention. On (b)(6), patient received a follow-up x ray. On (b)(6), patient was advised that the wire had passed and was released. Subsequently on (b)(6), patient felt a sharp wire in her mouth. An occlusal rest came off and the patient swallowed the wire. Patient sought treatment at the emergency room. X rays were taken to locate the wire. The wire was found in the small intestine. Patient was advised that wire would pass and to come back if she experienced cramping, bleeding or pain. The herbst appliance was seated on (b)(6) 2016 and was removed on (b)(6) 2016.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004158247-2016-00001 |
| MDR Report Key | 5776149 |
| Date Received | 2016-07-07 |
| Date of Report | 2016-06-02 |
| Date of Event | 2016-05-02 |
| Date Mfgr Received | 2016-06-02 |
| Device Manufacturer Date | 2016-02-16 |
| Date Added to Maude | 2016-07-07 |
| 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 | CAROLYN THOMAS |
| Manufacturer Street | 4905 HAMMOND INDUSTRIAL DRIVE |
| Manufacturer City | CUMMING GA 30041 |
| Manufacturer Country | US |
| Manufacturer Postal | 30041 |
| Manufacturer Phone | 6785134408 |
| Manufacturer G1 | SPECIALTY APPLIANCE WORKS, INC |
| Manufacturer Street | 4905 HAMMOND INDUSTRIAL DRIVE |
| Manufacturer City | CUMMING GA 30041 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30041 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HERBST |
| Generic Name | HERBST APPLIANCE |
| Product Code | EJF |
| Date Received | 2016-07-07 |
| Returned To Mfg | 2016-06-02 |
| Catalog Number | 10040T |
| Lot Number | 6469124 |
| Operator | DENTIST |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SPECIALTY APPLIANCE WORKS, INC |
| Manufacturer Address | 4905 HAMMOND INDUSTRIAL DRIVE CUMMING GA 30041 US 30041 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-07-07 |