MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07,08 report with the FDA on 2011-05-18 for MATRX OL-7 manufactured by Midmark Corp..
[19906799]
The compressor head came apart.
Patient Sequence No: 1, Text Type: D, B5
[19944890]
The device has not yet been returned at the time of this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1523530-2011-00012 |
| MDR Report Key | 2104870 |
| Report Source | 07,08 |
| Date Received | 2011-05-18 |
| Date of Report | 2011-05-17 |
| Date of Event | 2011-04-21 |
| Device Manufacturer Date | 2006-06-01 |
| Date Added to Maude | 2012-04-05 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | DONALD CARR |
| Manufacturer Street | 60 VISTA DR. |
| Manufacturer City | VERSAILLES OH 45380 |
| Manufacturer Country | US |
| Manufacturer Postal | 45380 |
| Manufacturer Phone | 9375263662 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MATRX |
| Generic Name | UNIT, OPERATIVE DENTAL, ACCESSORIES |
| Product Code | NRD |
| Date Received | 2011-05-18 |
| Model Number | OL-7 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MIDMARK CORP. |
| Manufacturer Address | VERSAILLES OH US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-05-18 |