MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08,distributor,foreign report with the FDA on 2015-07-09 for MICRO DEBRIDER A035300000100 manufactured by Dentsply Maillefer.
[6834930]
In this event it was reported that a micro debrider broke during use. The broken piece was retrieved with a saliva ejector.
Patient Sequence No: 1, Text Type: D, B5
[14214301]
There has been a previous report received where this malfunction with a similar device 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 21 cfr part 803. The device is available for evaluation, though has not been returned as of this report. Evaluation results will be submitted as they become available.
Patient Sequence No: 1, Text Type: N, H10
[63964399]
Involved product was not returned and cannot be analyzed. The provided batch number turns out to have no corresponding with the involved product catalog number. The right batch number is unknown, dhr cannot be reviewed. Root causes are not identified. We will track this kind of event and monitor the trend.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8031010-2015-00026 |
| MDR Report Key | 4910103 |
| Report Source | 01,08,DISTRIBUTOR,FOREIGN |
| Date Received | 2015-07-09 |
| Date of Report | 2015-06-09 |
| Date Mfgr Received | 2015-06-09 |
| Date Added to Maude | 2015-08-03 |
| 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 | 3 |
| Manufacturer Contact | HELEN LEWIS |
| Manufacturer Street | SUSQUEHANNA COMMERCE CENTER W. 221 W. PHILADELPHIA ST., STE. 60 |
| Manufacturer City | YORK PA 17401 |
| Manufacturer Country | US |
| Manufacturer Postal | 17401 |
| Manufacturer Phone | 7178457511 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MICRO DEBRIDER |
| Product Code | ELA |
| Date Received | 2015-07-09 |
| Catalog Number | A035300000100 |
| Lot Number | 1243430 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DENTSPLY MAILLEFER |
| Manufacturer Address | BALLAIGUES SZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-09 |