MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-04 for HERBST APPLIANCE 10040T manufactured by Specialty Appliance Works, Inc.
[82043282]
A doctor's office alleged that a patient swallowed a herbst appliance screw. Upon initial report, the mother confirmed that the patient passed the screw. The patient did not require any medical intervention to remove the screw. No complications or adverse symptoms have been noted. The doctor requested a replacement screw. The patient is continuing treatment with the original appliance and the replacement screw. The appliance was not returned so an evaluation could not be performed. The report was filed as a malfunction as a precaution due to lack of information.
Patient Sequence No: 1, Text Type: N, H10
[82043283]
A doctor's office alleged that a patient swallowed a herbst appliance screw. Upon initial report, the mother confirmed that the patient passed the screw. The patient did not require any medical intervention to remove the screw. No complications or adverse symptoms have been noted. The doctor requested a replacement screw. The patient is continuing treatment with the original appliance and the replacement screw. The appliance was not returned so an evaluation could not be performed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004158247-2017-00001 |
| MDR Report Key | 6768155 |
| Date Received | 2017-08-04 |
| Date of Report | 2017-08-04 |
| Date of Event | 2017-07-12 |
| Date Mfgr Received | 2017-07-12 |
| Device Manufacturer Date | 2017-06-23 |
| Date Added to Maude | 2017-08-04 |
| 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 | MS 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 APPLIANCE |
| Generic Name | HERBST SCREW |
| Product Code | ECN |
| Date Received | 2017-08-04 |
| Catalog Number | 10040T |
| Lot Number | 6640075 |
| Device Availability | N |
| Device Age | 1 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SPECIALTY APPLIANCE WORKS, INC |
| Manufacturer Address | 49005 HAMMOND INDUSTRIAL DRIVE CUMMING GA 30041 US 30041 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-08-04 |