MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2013-08-09 for RUSCH EMERALD FO MACINTOSH BLAD, SIZE 3 004433300 manufactured by Teleflex Medical.
[16008796]
The complaint was reported as: the customer alleges that the ball joint that locks the blade to the handle is sticking and they are unable to lock the blade on the handle. No report of a pt injury.
Patient Sequence No: 1, Text Type: D, B5
[16504859]
It is unknown if the device was used on a pt. No visual or functional inspection can be performed since the defective sample is not available for evaluation. A dhr (device history record) could not be conducted since the lot number was not provided. No corrective action can be established since the defective sample was not received for evaluation. No conclusion can be established at this time based on the lack of the defective sample. It is necessary to evaluate the physical sample in order to perform a proper investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004365956-2013-00258 |
| MDR Report Key | 3289884 |
| Report Source | 05,06,07 |
| Date Received | 2013-08-09 |
| Date of Report | 2013-07-22 |
| Date of Event | 2013-07-01 |
| Date Mfgr Received | 2013-07-22 |
| Date Added to Maude | 2013-11-04 |
| 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 | MARGIE BURTON, CLINICAL SPECIALI |
| Manufacturer Street | P.O. 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 EMERALD FO MACINTOSH BLAD, SIZE 3 |
| Generic Name | FIBEROPTIC LARYNGOSCOPE BLADE |
| Product Code | EQN |
| Date Received | 2013-08-09 |
| 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 MEDICAL |
| Manufacturer Address | NUEVO LAREDO MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-08-09 |