MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1997-08-28 for ALBIN EXCHANGE OBTURATOR C-CAE-14.0-83-DLT manufactured by Cook Inc..
[66949]
The exchange obturator was being utilized to change an endotracheal tube due to a cuff leak. The physician thought the insertion was relatively atraumatic without encountering any resistance. The new endotracheal tube was inserted and the obturator removed. The pt coughed up bright blood and continued to bleed. He expired a short time later.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-1997-00092 |
| MDR Report Key | 115972 |
| Report Source | 05 |
| Date Received | 1997-08-28 |
| Date of Report | 1997-08-01 |
| Date of Event | 1997-07-21 |
| Date Facility Aware | 1997-07-21 |
| Report Date | 1997-08-01 |
| Date Mfgr Received | 1997-08-01 |
| Date Added to Maude | 1997-08-29 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALBIN EXCHANGE OBTURATOR |
| Generic Name | EXCHANGE OBTURATOR |
| Product Code | FEC |
| Date Received | 1997-08-28 |
| Model Number | NA |
| Catalog Number | C-CAE-14.0-83-DLT |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 113792 |
| Manufacturer | COOK INC. |
| Manufacturer Address | 925 S. CURRY PIKE BLOOMINGTON IN 47403 US |
| Baseline Brand Name | ALBIN EXCHANGE OBTURATOR |
| Baseline Generic Name | EXCHANGE OBTURATOR |
| Baseline Model No | NA |
| Baseline Catalog No | C-CAE-14.0-83-DLT |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 1997-08-28 |