MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-08-01 for MELKER EMERGENCY CUFFED SPECIAL OPERATIONS CRICOTHYROTOY CATHETER SET C-TCCSB-500-SPOPS manufactured by Cook Inc.
[4690198]
During a cricothyrotomy on a large (overweight) pt, the included disposable scalpel was too small to cut through all of the tissue in order to create an airway. The pt expired. The user facility is not claiming the device is at fault for the pt outcome. However, it was recommended that a larger scalpel be included, to accommodate all type of pts.
Patient Sequence No: 1, Text Type: D, B5
[12232115]
Date of death unk. Device code - it appears there was nothing wrong with the supplied scalpel but that it was not long enough to see on an obese pt. No mention of pt size in the ifu. Event evaluation: still under investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1820334-2014-00350 |
| MDR Report Key | 3999532 |
| Report Source | 07 |
| Date Received | 2014-08-01 |
| Date of Report | 2014-07-16 |
| Report Date | 2014-07-16 |
| Date Mfgr Received | 2014-07-17 |
| Date Added to Maude | 2014-08-12 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | RITA HARDEN, DIRECTOR |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MELKER EMERGENCY CUFFED SPECIAL OPERATIONS CRICOTHYROTOY CATHETER SET |
| Generic Name | BWC NEEDLE, EMERGENCY AIRWAY |
| Product Code | BWC |
| Date Received | 2014-08-01 |
| Model Number | NA |
| Catalog Number | C-TCCSB-500-SPOPS |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC |
| Manufacturer Address | BLOOMINGTON IN 47402 US 47402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2014-08-01 |