MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07,08 report with the FDA on 2013-01-23 for RUSCH EMERALD FIBER OPTIC MACINTOSH BLADE 3 004433300 manufactured by Teleflex.
[3239760]
The complaint is reported as: the customer was unable to detach the blade from the handle after intubation. No pt injury reported.
Patient Sequence No: 1, Text Type: D, B5
[10445346]
The device history record (dhr) review could not be performed as the lot number was unk. The sample was not returned for eval, therefore, the complaint could not be confirmed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004365956-2013-00021 |
| MDR Report Key | 2934703 |
| Report Source | 06,07,08 |
| Date Received | 2013-01-23 |
| Date of Report | 2012-01-02 |
| Date of Event | 2012-12-26 |
| Date Mfgr Received | 2012-01-02 |
| Date Added to Maude | 2013-04-15 |
| 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 | KATHARINE TARPLEY |
| Manufacturer Street | PO 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, TAMAULIPAS 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 EMERALD FIBER OPTIC MACINTOSH BLADE 3 |
| Generic Name | LARYNGOSCOPE BLADE |
| Product Code | EQN |
| Date Received | 2013-01-23 |
| Catalog Number | 004433300 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX |
| Manufacturer Address | NUEVO LAREDO MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-01-23 |