MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,08 report with the FDA on 2004-10-28 for OROPHARYNGEAL AIRWAY 330006 manufactured by Smiths Medical Asd, Inc..
[311096]
The user alleges that a piece of paper was in the guedel airway unit and it was not noticed until it was put into the pt. The pt took a deep breath and the paper went inside. There was an anesthestist there who was able to use mcgill forceps to remove the paper.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1217052-2004-00088 |
| MDR Report Key | 552089 |
| Report Source | 01,05,06,08 |
| Date Received | 2004-10-28 |
| Date of Report | 2004-10-21 |
| Date of Event | 2004-09-13 |
| Date Mfgr Received | 2004-10-21 |
| Device Manufacturer Date | 2003-08-01 |
| Date Added to Maude | 2004-10-29 |
| 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 | TIMOTHY MATSON |
| Manufacturer Street | * |
| Manufacturer City | KEENE NH 03431 |
| Manufacturer Country | US |
| Manufacturer Postal | 03431 |
| Manufacturer Phone | 6033523812 |
| Manufacturer G1 | SMITHS MEDICAL ASD, INC. |
| Manufacturer Street | * |
| Manufacturer City | KEENE NH 03431 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 03431 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OROPHARYNGEAL AIRWAY |
| Generic Name | AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY |
| Product Code | LAE |
| Date Received | 2004-10-28 |
| Returned To Mfg | 2004-10-28 |
| Model Number | NA |
| Catalog Number | 330006 |
| Lot Number | K199784 |
| ID Number | NA |
| Device Expiration Date | 2008-07-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 541623 |
| Manufacturer | SMITHS MEDICAL ASD, INC. |
| Manufacturer Address | 10 BOWMAN DR. KEENE NH 03431 US |
| Baseline Brand Name | OROPHARYNGEAL AIRWAY |
| Baseline Generic Name | AIRWAY, OROPHARYNGEAL, ANESTHESLOGY |
| Baseline Model No | NA |
| Baseline Catalog No | 330006 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-10-28 |