MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2006-10-24 for SHILEY LGT 8LGT manufactured by Juarez Henequen.
[538156]
On 10/04/06, nellcor rec'd a report where it was claimed "leakage between inner and outer cannula" while in use on a pt. Replacement of the tube was required.
Patient Sequence No: 1, Text Type: D, B5
[7918729]
Investigation of this report is currently in progress.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2936999-2006-00832 |
| MDR Report Key | 772874 |
| Report Source | 06 |
| Date Received | 2006-10-24 |
| Date of Report | 2006-10-04 |
| Date of Event | 2006-10-01 |
| Date Mfgr Received | 2006-10-04 |
| Device Manufacturer Date | 2003-08-01 |
| Date Added to Maude | 2006-10-26 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | RENEE SAAVEDRA, ANALYST |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Manufacturer Phone | 9254634472 |
| Manufacturer G1 | JUAREZ HENEQUEN |
| Manufacturer Street | AVENIDA HENEQUEN 1181 PARQUE INDUST. SALVARCAR |
| Manufacturer City | CD. JUAREZ |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SHILEY |
| Generic Name | LARYNGECTOMY |
| Product Code | KAC |
| Date Received | 2006-10-24 |
| Model Number | LGT |
| Catalog Number | 8LGT |
| Lot Number | 0308000359 |
| ID Number | * |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 760659 |
| Manufacturer | JUAREZ HENEQUEN |
| Manufacturer Address | AVENIDA HENEQUEN CD JUAREZ, CHIHUAHUA MX |
| Baseline Brand Name | SHILEY |
| Baseline Generic Name | LARYNGECTOMY |
| Baseline Model No | LGT |
| Baseline Catalog No | 8LGT |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-10-24 |