MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-06-13 for PANORAMIC X-RAY MODEL PC-1000 800724-1 manufactured by Young Innovations.
[111058098]
The dentist emailed and stated that the screw motor assembly failed. The overhead chassis lightly made contact with a girl. The dentist applied antibiotic and a band-aid. The mother took the girl to the physician to make sure she was alright. The physician reapplied antibiotic and a band-aid. The girl was not hospitalized. The dentist purchased a screw motor and had it shipped to his office. He is having his own technician replace the motor since there are no panoramic certified technicians in (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[111058099]
Dr. (b)(6) notified us be email on (b)(6) 2018 that three weeks prior (1st week of (b)(6)approximately), a patient was entering the unit and the screw motor assembly failed. The overhead chassis made contact with the patient. On (b)(6) 2018, the doctor gave us the serial number and other required information for this incident so we could investigate and create a case. The screw motor is stuck now and will not go up. The patient was scraped on the cheek and shoulder. The patient was treated with antibiotic and a band-aid on the cheek.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1832462-2018-00003 |
| MDR Report Key | 7598026 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-06-13 |
| Date of Report | 2018-06-13 |
| Date of Event | 2018-05-02 |
| Date Mfgr Received | 2018-05-23 |
| Device Manufacturer Date | 1998-06-23 |
| Date Added to Maude | 2018-06-13 |
| 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 | ADRIENNE DEMLAND |
| Manufacturer Street | 4321 GOSHEN RD. |
| Manufacturer City | FORT WAYNE IN 46818 |
| Manufacturer Country | US |
| Manufacturer Postal | 46818 |
| Manufacturer Phone | 8006542027 |
| Manufacturer G1 | YOUNG INNOVATIONS |
| Manufacturer Street | 4321 GOSHEN RD. |
| Manufacturer City | FORT WAYNE IN 46818 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46818 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PANORAMIC X-RAY MODEL PC-1000 |
| Generic Name | PC-1000 |
| Product Code | EHD |
| Date Received | 2018-06-13 |
| Model Number | 800724-1 |
| Operator | DENTIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | YOUNG INNOVATIONS |
| Manufacturer Address | 4321 GOSHEN RD. FORT WAYNE IN 46818 US 46818 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-06-13 |