MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-07-12 for SYSTEM B HEAT SOURCE 952-0001 manufactured by Sybronendo.
[11074058]
A visual and physical evaluation of the returned device revealed that a spring was bent on the device, causing constant heating.
Patient Sequence No: 1, Text Type: N, H10
[20354398]
A doctor alleged that the system b heat source device continued to heat after being unplugged and the doctor had burned the index finger on his left hand while attempting to remove the tip.
Patient Sequence No: 1, Text Type: D, B5
[20556411]
The doctor confirmed that no medical attention or prescription medication was required. The doctor iced his hand for a brief period and the burn healed on its own after a few days. A device evaluation is anticipated, but has not yet begun.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2016150-2013-00071 |
| MDR Report Key | 3222655 |
| Report Source | 05 |
| Date Received | 2013-07-12 |
| Date of Report | 2013-06-13 |
| Date Mfgr Received | 2013-06-13 |
| Date Added to Maude | 2013-10-03 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MRS. KERRI CASINO |
| Manufacturer Street | 1717 W. COLLINS AVE |
| Manufacturer City | ORANGE CA 29867 |
| Manufacturer Country | US |
| Manufacturer Postal | 29867 |
| Manufacturer Phone | 7145167634 |
| Manufacturer G1 | SYBRONENDO |
| Manufacturer Street | 1332 SOUTH LONE HILL AVENUE |
| Manufacturer City | GLENDORA CA 91740 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 91740 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYSTEM B HEAT SOURCE |
| Generic Name | PULP TESTER |
| Product Code | EAT |
| Date Received | 2013-07-12 |
| Catalog Number | 952-0001 |
| Lot Number | 15-1908 |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYBRONENDO |
| Manufacturer Address | 1332 SOUTH LONE HILL AVENUE GLENDORA CA 91740 US 91740 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-07-12 |