MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2008-01-30 for E4D DENTIST E4D-DOS1 manufactured by D4d Technologies, Llc.
[19160915]
It was reported that one of the rubber boots on the standoff came off during the intra oral scanning process and the pt swallowed the piece before it could be retrieved by the dentist. There was no injury and the boot was replaced and the procedure completed. The pt did not consult a physician and follow up by the dentist did not reveal any health issues. It was assumed the piece had been passed through the intestinal tract.
Patient Sequence No: 1, Text Type: D, B5
[19325104]
Clinical performance and review of stand-off and bootie: clinical evaluation to determine if the design specifications and resulting product (bootie and standoff) met or exceeded clinical performance according to instructions for use and normal operating conditions. In 2008, a new clinical operator was observed utilizing all sizes of the bootie (6mm, 8mm, 10mm) to scan anterior and posterior preparations. No add'l instruction was given. The operator performed over 100 scans without any incidence of the booties coming loose or dislodging. In some cases, a single set of booties was used to perform 30 consecutive scans. Three days later, an experienced clinical operator performed several sets (9) of clinical scans on the most distal tooth (#31) using the yellow booties in the lower arch. No dislodgement occurred during rotations and no discomfort was observed by the pt. Review of clinical results, support calls and questionnaires of existing eco members (d4d clinical operators) revealed only one incidence of reporting by an observer that the booties came off during operation and were a non-issue to the pt. Clinical summary: through initial but extensive use of the booties of various sizes, when used under normal and instructed operating conditions, the booties meet the clinical requirements as designed. Instructions for use and clinical demonstration will alert the clinician of possible hazards related to the boot and the proper techniques to use in order to minimize these hazards.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004998675-2008-00001 |
| MDR Report Key | 990799 |
| Report Source | 05,08 |
| Date Received | 2008-01-30 |
| Date of Report | 2008-01-03 |
| Date of Event | 2008-01-03 |
| Date Mfgr Received | 2008-01-03 |
| Device Manufacturer Date | 2007-12-01 |
| Date Added to Maude | 2009-12-30 |
| 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 | 0 |
| Manufacturer Contact | EDDIE ANDERSON |
| Manufacturer Street | 630 INTERNATIONAL PKWY. # 150 |
| Manufacturer City | RICHARDSON TX 75081 |
| Manufacturer Country | US |
| Manufacturer Postal | 75081 |
| Manufacturer Phone | 9722343880 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | E4D DENTIST |
| Product Code | NOF |
| Date Received | 2008-01-30 |
| Model Number | E4D-DOS1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | D4D TECHNOLOGIES, LLC |
| Manufacturer Address | RICHARDSON TX US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-01-30 |