MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-09-29 for SATIN SLIP 85863 manufactured by Respiratory.
[37008474]
The hospital has not returned this device to nellcor and therefore eval is not possible at this time. If the device is received, a supplemental or corrected report will be provided to the fda following completion of the eval.
Patient Sequence No: 1, Text Type: N, H10
[37008475]
During a diaper change, the infant coughed and the attending rn noted small tube in patient's throat. Tube removed by otolaryngologist. Patient has since been discharged from hospital.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2936999-2004-00033 |
| MDR Report Key | 5317948 |
| Date Received | 2004-09-29 |
| Date of Report | 2004-09-29 |
| Date Mfgr Received | 2004-08-31 |
| Date Added to Maude | 2015-12-22 |
| 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 | 3 |
| Manufacturer Contact | AMBER SIMINPOUR, QA ANALYST |
| Manufacturer Street | 4280 HACIENDA DR. |
| Manufacturer City | PLEASANTON CA 94588 |
| Manufacturer Country | US |
| Manufacturer Postal | 94588 |
| Manufacturer Phone | 9254634476 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SATIN SLIP |
| Generic Name | INTUBATION STYLET STERILE |
| Product Code | FSQ |
| Date Received | 2004-09-29 |
| Catalog Number | 85863 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RESPIRATORY |
| Manufacturer Address | 4280 HACIENDA DR. PLEASANTON CA 94588 US 94588 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2004-09-29 |