MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05,06 report with the FDA on 2005-09-01 for CATH OXYGEN CANNULA 10FR K21 manufactured by Cardinal Health.
[15482853]
Per medwatch report received, "doctor had just placed nasopharyngeal catheter into pt nares with 5 liters of oxygen and pt stated pain in left chest, immediately followed by complaints of abdominal pain. Pt then began to have respiratory problems, face became very swollen and had crepilus in chest and distended abdomen. Code blue was called and pt was intubated. Went to surgery about an hour later for suspected perforation, none found. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423507-2005-00109 |
| MDR Report Key | 632322 |
| Report Source | 00,05,06 |
| Date Received | 2005-09-01 |
| Date of Report | 2005-09-01 |
| Date of Event | 2005-07-01 |
| Date Mfgr Received | 2005-08-08 |
| Device Manufacturer Date | 2004-04-01 |
| Date Added to Maude | 2005-09-06 |
| 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 | MICHELE DONATICH |
| Manufacturer Street | 1430 WAUKEGAN RD. BLDG K8 |
| Manufacturer City | MCGAW PARK IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8475786412 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | MEXICALI |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CATH OXYGEN CANNULA 10FR |
| Generic Name | OXYGEN CATHETER |
| Product Code | BZB |
| Date Received | 2005-09-01 |
| Model Number | K21 |
| Catalog Number | K21 |
| Lot Number | Y4D0714 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 621890 |
| Manufacturer | CARDINAL HEALTH |
| Manufacturer Address | * MCGAW PARK IL * US |
| Baseline Brand Name | CATH OXYGEN CANNULA 10FR |
| Baseline Generic Name | OXYGEN CATHETER |
| Baseline Model No | K21 |
| Baseline Catalog No | K21 |
| Baseline ID | NA |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2005-09-01 |