MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-08-12 for RUSCH GREENSPEC FO HANDLE, SMALL 004412200 manufactured by Teleflex Medical.
[3604024]
The complaint was reported as: the customer alleges that the handle gets hot when attached to the laryngoscope blade. The alleged defect occurred prior to pt use and during pre-testing. No report of a pt injury.
Patient Sequence No: 1, Text Type: D, B5
[11005047]
No visual and functional inspection can be performed since the defective sample is not available for eval. The device history record (dhr) of batch number 02e1302659 has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint. No non conformance reports were originated for the lot in question that can be associated to the complaint reported. Dhr shows that the product was assembled and inspected according to our specifications. No corrective action can be established since the defective sample was not rec'd for eval. No conclusion can be established at this time based on the lack of defective of sample. It is necessary to have the physical sample in order to perform a properly investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004365956-2013-00260 |
| MDR Report Key | 3289926 |
| Report Source | 06 |
| Date Received | 2013-08-12 |
| Date of Report | 2013-07-26 |
| Date of Event | 2013-07-19 |
| Date Mfgr Received | 2013-07-26 |
| Device Manufacturer Date | 2013-05-01 |
| Date Added to Maude | 2013-11-07 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARGIE BURTON, RA CLINICAL SPECI |
| Manufacturer Street | PO BOX 12600 |
| Manufacturer City | DURHAM NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 9194334965 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RUSCH GREENSPEC FO HANDLE, SMALL |
| Generic Name | LARYNGOSCOPE FO HANDLE |
| Product Code | GDZ |
| Date Received | 2013-08-12 |
| Catalog Number | 004412200 |
| Lot Number | 02E1302659 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | NUEVO LAREDO MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-08-12 |