MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2011-02-23 for RUSCH GREENSPEC FIBEROPTIC HANDLE MEDIUM 004411100 manufactured by Teleflex Medical.
[17397940]
The event is reported as: handle becomes extremely hot to the point that the care givers are unable to hold them. The handles are also melting the batteries. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
[17656834]
Product has been received by manufacturer, however, investigation report is incomplete at this time. A follow-up report will be submitted when investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004365956-2011-00069 |
| MDR Report Key | 2043083 |
| Report Source | 06,07 |
| Date Received | 2011-02-23 |
| Date of Report | 2011-01-31 |
| Date of Event | 2011-01-31 |
| Date Mfgr Received | 2011-01-31 |
| Date Added to Maude | 2011-06-13 |
| 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 | KATHARINE TARPLEY |
| Manufacturer Street | P.O. BOX 12600 |
| Manufacturer City | RTP NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 9194334854 |
| Manufacturer G1 | TELEFLEX |
| Manufacturer Street | AVE. TRANSFORMACION 5954 PARQUE INDUSTRIAL FINSA |
| Manufacturer City | NUEVO LAREDO 88275 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 88275 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RUSCH GREENSPEC FIBEROPTIC HANDLE MEDIUM |
| Generic Name | GREENSPEC FIBEROPTIC HANDLE |
| Product Code | EQN |
| Date Received | 2011-02-23 |
| Returned To Mfg | 2011-02-09 |
| Model Number | NA |
| Catalog Number | 004411100 |
| Lot Number | UNKNOWN |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | NUEVO LAREDO MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-02-23 |