MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2013-08-26 for TOUCH N' HEAT 973-0212 manufactured by Sybronendo.
[3590242]
A doctor's office had alleged that two (2) touch n' heat units had continued heating up when not in use and plugged in. This is the first of two (2) reports.
Patient Sequence No: 1, Text Type: D, B5
[11017527]
No further information was received with regard to this incident. Multiple attempts were made to contact the complainant in order to obtain further information; however, the complainant has remained unresponsive. An update will be provided if any new information becomes available. 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
| Report Number | 2016150-2013-00100 |
| MDR Report Key | 3307084 |
| Report Source | 08 |
| Date Received | 2013-08-26 |
| Date of Report | 2013-07-26 |
| Date Mfgr Received | 2013-07-26 |
| Date Added to Maude | 2013-11-22 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TOUCH N' HEAT |
| Generic Name | PULP TESTER |
| Product Code | EAT |
| Date Received | 2013-08-26 |
| Catalog Number | 973-0212 |
| Operator | OTHER |
| Device Availability | Y |
| 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 | 2013-08-26 |