MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-28 for MIDWEST E PRO 1:5 875105 manufactured by Sirona Dental Systems Gmbh.
[184707253]
Additional serial numbers included in this report: (b)(4). 18 of 18 devices were returned for evaluation. Evaluation of two returned devices found excessive wear due to a lack of proper maintenance. There was also evidence of debris build-up. The devices did not heat up during evaluation. The devices were repaired and returned to the customer. Evaluation of one returned device found excessive wear due to a lack of proper maintenance. There was also a lack of lubrication and evidence of debris build-up. This device did heat up during evaluation. The device was repaired and returned to the customer. Evaluation of three returned devices found excessive wear due to a lack of proper maintenance. The devices did not heat up during evaluation. The devices were repaired and returned to the customer. Evaluation of 12 returned devices found excessive wear due to a lack of proper maintenance. There was also evidence of debris build-up. The devices did not heat up during evaluation. The devices were repaired and returned to the customer.
Patient Sequence No: 1, Text Type: N, H10
[184707254]
This report summarizes
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9614977-2019-00163 |
| MDR Report Key | 9639597 |
| Date Received | 2020-01-28 |
| Date of Report | 2020-01-28 |
| Date Added to Maude | 2020-01-28 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| 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, 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 PRO 1:5 |
| Generic Name | HANDPIECE, AIR-POWERED, DENTAL |
| Product Code | EFB |
| Date Received | 2020-01-28 |
| Model Number | NA |
| Catalog Number | 875105 |
| Lot Number | NA |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| 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 | 2020-01-28 |