MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-04-12 for MIDWEST E PLUS 1:5 HIGHSPEED ATTACHMENT 875205 manufactured by Sirona Dental Systems Gmbh.
[141763739]
While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such. As such, this event is reportable per 21cfr part 803. Handpiece didnt get hot. Handpiece failed specs due to cap sticking coming intact with rotor. Cap has white paste/debris on side of cap cause the cap to stick inwards position when pressed.
Patient Sequence No: 1, Text Type: N, H10
[141763740]
It was reported that a midwest e plus 1:5 ca overheated during use and burned a patient's cheek; no intervention was required.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9614977-2019-00049 |
| MDR Report Key | 8508996 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-04-12 |
| Date of Report | 2019-04-05 |
| Date Added to Maude | 2019-04-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | MR. KARL NITTINGER |
| Manufacturer Street | 221 W. PHILADELPHIA ST. SUITE 60W |
| Manufacturer City | YORK PA 17401 |
| Manufacturer Country | US |
| Manufacturer Postal | 17401 |
| Manufacturer Phone | 7178494424 |
| Manufacturer G1 | SIRONA DENTAL SYSTEMS GMBH |
| Manufacturer Street | FABRIKSTRASSE 31 |
| Manufacturer City | BENSHEIM, HESSEN D-64625 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D-64625 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MIDWEST E PLUS 1:5 HIGHSPEED ATTACHMENT |
| Generic Name | HANDPIECE, BELT AND/OR GEAR DRIVEN, DENTAL |
| Product Code | EFA |
| Date Received | 2019-04-12 |
| Returned To Mfg | 2019-03-15 |
| Model Number | NA |
| Catalog Number | 875205 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIRONA DENTAL SYSTEMS GMBH |
| Manufacturer Address | FABRIKSTRASSE 31 BENSHEIM, D-64625 GM D-64625 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-12 |