MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-08-28 for PANORAMIC X-RAY MODEL PC-1000 800724-3 manufactured by Young Innovations.
[118553405]
The ceph head was not clamped down correctly and a string was attached to secure the ceph head. The doctor said the reason it was not clamped down was he could not get the screws back in correctly. Panoramic sent a technician out to insure the ceph head was secured and the machine is working properly. The machine was operating properly and the ceph head was reclamped down. Picture attached. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[118553406]
Dr (b)(6) mentioned the ceph head fell off the machine and near his foot. There was no injury and no medical treatment was necessary. This incident occurred about a month and half ago.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1832462-2018-00005 |
| MDR Report Key | 7823373 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-08-28 |
| Date of Report | 2018-08-27 |
| Date Mfgr Received | 2018-08-09 |
| Device Manufacturer Date | 2000-02-23 |
| Date Added to Maude | 2018-08-28 |
| 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 | MRS TAMMY SHIFFLER |
| Manufacturer Street | 4321 GOSHEN ROAD |
| Manufacturer City | FORT WAYNE IN 46818 |
| Manufacturer Country | US |
| Manufacturer Postal | 46818 |
| Manufacturer Phone | 8006542027 |
| Manufacturer G1 | YOUNG INNOVATIONS |
| Manufacturer Street | 4321 GOSHEN ROAD |
| 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 / LASER 1000 |
| Product Code | EHD |
| Date Received | 2018-08-28 |
| Model Number | 800724-3 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | YOUNG INNOVATIONS |
| Manufacturer Address | 4321 GOSHEN ROAD FORT WAYNE IN 46818 US 46818 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-08-28 |