MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2018-02-20 for HERBST APPLIANCE 10045T manufactured by Specialty Appliance Works, Inc.
[100462589]
On (b)(6) 2018, specialty appliances received a letter from a patient's parent stating that her son swallowed a broken part from a herbst appliance. The letter stated that the incident occurred on (b)(6) 2017. On (b)(6) 2017 the patient was seen in the emergency room. An x-ray showed a metallic structure overlying the upper right quadrant of the abdomen. On (b)(6) 2017 the patient developed a fever and stomach cramps. On (b)(6) 2017 a second x-ray was taken and it was confirmed that the metallic structure passed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004158247-2018-00001 |
| MDR Report Key | 7282634 |
| Report Source | OTHER |
| Date Received | 2018-02-20 |
| Date of Report | 2018-01-26 |
| Date of Event | 2017-03-23 |
| Date Mfgr Received | 2018-01-26 |
| Device Manufacturer Date | 2016-08-10 |
| Date Added to Maude | 2018-02-20 |
| 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 | 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 | 3 |
| Brand Name | HERBST APPLIANCE |
| Generic Name | HERBST APPLIANCE |
| Product Code | ECN |
| Date Received | 2018-02-20 |
| Catalog Number | 10045T |
| Lot Number | 6526811 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SPECIALTY APPLIANCE WORKS, INC |
| Manufacturer Address | 4905 HAMMOND INDUSTRIALDRIVE CUMMING 30041 US 30041 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-02-20 |